{ "FullStudy":{ "Rank":218144, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512160", "OrgStudyIdInfo":{ "OrgStudyId":"B1351010" }, "Organization":{ "OrgFullName":"Pfizer", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain", "OfficialTitle":"A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control" }, "StatusModule":{ "StatusVerifiedDate":"May 2013", "OverallStatus":"Terminated", "WhyStopped":"See termination reason in detailed description.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"August 30, 2011", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 14, 2013", "ResultsFirstSubmitQCDate":"May 23, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 28, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 23, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 28, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Pfizer", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Post-surgical Dental Pain" ] }, "KeywordList":{ "Keyword":[ "Post-surgical dental pain" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"90", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"PF-04531083 2000 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04531083", "Other: Placebo" ] } },{ "ArmGroupLabel":"PF-04531083 1000 mg", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04531083", "Other: Placebo" ] } },{ "ArmGroupLabel":"Ibuprofen 400 mg", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Ibuprofen", "Other: Placebo" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"PF-04531083", "InterventionDescription":"2000 mg oral solution", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04531083 2000 mg" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo tablets for Ibuprofen", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04531083 2000 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"PF-04531083", "InterventionDescription":"1000 mg oral solution", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04531083 1000 mg" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo tablets for Ibuprofen", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04531083 1000 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Ibuprofen", "InterventionDescription":"2 x 200 mg tablets", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ibuprofen 400 mg" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo solution for PF-04531083", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ibuprofen 400 mg" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo solution for PF-04531083", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Other", "InterventionName":"Placebo", "InterventionDescription":"Placebo tablets for Ibuprofen", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Total Pain Relief (TOTPAR) Score From 0 to 6 Hours", "PrimaryOutcomeDescription":"TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.", "PrimaryOutcomeTimeFrame":"0 to 6 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants With Peak Pain Relief (PPR)", "SecondaryOutcomeDescription":"PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).", "SecondaryOutcomeTimeFrame":"0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Time-specific Pain Relief (PR) Score", "SecondaryOutcomeDescription":"PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.", "SecondaryOutcomeTimeFrame":"0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)" },{ "SecondaryOutcomeMeasure":"Time-specific Pain Intensity Difference (PID) Score", "SecondaryOutcomeDescription":"Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.", "SecondaryOutcomeTimeFrame":"15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM" },{ "SecondaryOutcomeMeasure":"Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours", "SecondaryOutcomeDescription":"Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.", "SecondaryOutcomeTimeFrame":"0 to 6, 0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Total Pain Relief (TOTPAR) Score From 0 to 24 Hours", "SecondaryOutcomeDescription":"TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.", "SecondaryOutcomeTimeFrame":"0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Time to Onset of First Perceptible Pain Relief (PR)", "SecondaryOutcomeDescription":"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.", "SecondaryOutcomeTimeFrame":"0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Time to Onset of First Meaningful Pain Relief (PR)", "SecondaryOutcomeDescription":"Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.", "SecondaryOutcomeTimeFrame":"0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Time to First Use of Rescue Medication", "SecondaryOutcomeDescription":"Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.", "SecondaryOutcomeTimeFrame":"1.5 to 24 hours" },{ "SecondaryOutcomeMeasure":"Number of Participants With Rescue Medication", "SecondaryOutcomeDescription":"Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.", "SecondaryOutcomeTimeFrame":"0 to 24 hours" },{ "SecondaryOutcomeMeasure":"Participant Global Evaluation of Study Medication", "SecondaryOutcomeDescription":"Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.", "SecondaryOutcomeTimeFrame":"6, 24 hours, prior to RM" },{ "SecondaryOutcomeMeasure":"Participant Satisfaction Questionnaire", "SecondaryOutcomeDescription":"Participant's response to 2 questions about \"how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)\" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.", "SecondaryOutcomeTimeFrame":"6, 24 hours, prior to RM" },{ "SecondaryOutcomeMeasure":"Maximum Observed Plasma Concentration (Cmax) of PF-04531083", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083", "SecondaryOutcomeDescription":"AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6 hours post-dose" },{ "SecondaryOutcomeMeasure":"Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083", "SecondaryOutcomeDescription":"AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Maximum Observed Plasma Concentration (Cmax) of Ibuprofen", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen", "SecondaryOutcomeDescription":"AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6 hours post-dose" },{ "SecondaryOutcomeMeasure":"Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen", "SecondaryOutcomeDescription":"AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.", "SecondaryOutcomeTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose" },{ "SecondaryOutcomeMeasure":"Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)", "SecondaryOutcomeDescription":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.", "SecondaryOutcomeTimeFrame":"Baseline up to Day 10-14 (Follow-up)" },{ "SecondaryOutcomeMeasure":"Number of Participants With Clinically Significant Laboratory Test Abnormality", "SecondaryOutcomeDescription":"Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.", "SecondaryOutcomeTimeFrame":"Baseline up to Day 10-14 (Follow-up)" },{ "SecondaryOutcomeMeasure":"Supine Systolic and Diastolic Blood Pressure (BP)", "SecondaryOutcomeDescription":"Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.", "SecondaryOutcomeTimeFrame":"Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)" },{ "SecondaryOutcomeMeasure":"12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)", "SecondaryOutcomeDescription":"Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).", "SecondaryOutcomeTimeFrame":"Screening, Day 1, 2, 10-14 (Follow-up)" },{ "SecondaryOutcomeMeasure":"12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)", "SecondaryOutcomeDescription":"Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.", "SecondaryOutcomeTimeFrame":"Screening, Day 1, 2, 10-14 (Follow-up)" },{ "SecondaryOutcomeMeasure":"Supine Pulse Rate", "SecondaryOutcomeDescription":"Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.", "SecondaryOutcomeTimeFrame":"Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nOral surgical procedure having removed 2 third molars (unilateral).\nPre-dose pain intensity score (100 mm Visual Analog Scale [VAS]) >50 mm within 5 hours of oral surgery.\nPre-dose pain intensity score of moderate or within 5 hours of oral surgery.\n\nExclusion Criteria:\n\nPresence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.\nPrior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.\nRecent history of chronic analgesic or tranquilizer dependency.\nActive dental infection at the time of surgery.\nAny significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting > 30 minutes.\nSubjects who are smokers.", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"18 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Pfizer CT.gov Call Center", "OverallOfficialAffiliation":"Pfizer", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Austin", "LocationState":"Texas", "LocationZip":"78744", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"To obtain contact information for a study center near you, click here.", "SeeAlsoLinkURL":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351010&StudyName=Efficacy%20Of%20Pf-04531083%20In%20Treating%20Post-Surgical%20Dental%20Pain" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"PF-04531083 1000 mg", "FlowGroupDescription":"Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS)." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"PF-04531083 2000 mg", "FlowGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Ibuprofen 400 mg", "FlowGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"23" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"22" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"22" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"PF-04531083 1000 mg", "BaselineGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"PF-04531083 2000 mg", "BaselineGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Ibuprofen 400 mg", "BaselineGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"22" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"23" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"22" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"23" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"90" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22.9", "BaselineMeasurementSpread":"3.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"23.4", "BaselineMeasurementSpread":"5.7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"25.3", "BaselineMeasurementSpread":"4.5" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"25.3", "BaselineMeasurementSpread":"5.4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"24.2", "BaselineMeasurementSpread":"4.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"90" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Total Pain Relief (TOTPAR) Score From 0 to 6 Hours", "OutcomeMeasureDescription":"TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.", "OutcomeMeasurePopulationDescription":"Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale*hour", "OutcomeMeasureTimeFrame":"0 to 6 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.3", "OutcomeMeasurementSpread":"1.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.4", "OutcomeMeasurementSpread":"1.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.8", "OutcomeMeasurementSpread":"1.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.3", "OutcomeMeasurementSpread":"1.5" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Least squares (LS) mean difference", "OutcomeAnalysisParamValue":"-1.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-4.3", "OutcomeAnalysisCIUpperLimit":"2.2", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.9" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-0.9", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-4.1", "OutcomeAnalysisCIUpperLimit":"2.3", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.9" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"3.5", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.3", "OutcomeAnalysisCIUpperLimit":"6.7", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.9" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Peak Pain Relief (PPR)", "OutcomeMeasureDescription":"PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"None", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"A Little", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Some", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"A Lot", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Complete", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time-specific Pain Relief (PR) Score", "OutcomeMeasureDescription":"PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"0 hours (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementSpread":"0.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementSpread":"0.00" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementSpread":"0.00" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementSpread":"0.00" } ] } } ] } },{ "OutcomeClassTitle":"15 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.59", "OutcomeMeasurementSpread":"0.80" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.78", "OutcomeMeasurementSpread":"0.95" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.59", "OutcomeMeasurementSpread":"0.91" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.57", "OutcomeMeasurementSpread":"0.73" } ] } } ] } },{ "OutcomeClassTitle":"30 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementSpread":"0.85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.04", "OutcomeMeasurementSpread":"1.07" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.23", "OutcomeMeasurementSpread":"1.23" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.04", "OutcomeMeasurementSpread":"1.02" } ] } } ] } },{ "OutcomeClassTitle":"45 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementSpread":"0.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.26", "OutcomeMeasurementSpread":"1.18" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.55", "OutcomeMeasurementSpread":"1.22" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.35", "OutcomeMeasurementSpread":"1.07" } ] } } ] } },{ "OutcomeClassTitle":"1 hour (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.86", "OutcomeMeasurementSpread":"0.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.13", "OutcomeMeasurementSpread":"1.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.73", "OutcomeMeasurementSpread":"1.28" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.39", "OutcomeMeasurementSpread":"1.34" } ] } } ] } },{ "OutcomeClassTitle":"1.5 hours (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementSpread":"0.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementSpread":"1.12" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.77", "OutcomeMeasurementSpread":"1.38" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.30", "OutcomeMeasurementSpread":"1.22" } ] } } ] } },{ "OutcomeClassTitle":"2 hours (n=15, 13, 20, 16)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementSpread":"0.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.77", "OutcomeMeasurementSpread":"0.93" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.90", "OutcomeMeasurementSpread":"1.37" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.63", "OutcomeMeasurementSpread":"1.26" } ] } } ] } },{ "OutcomeClassTitle":"3 hours (n=11, 10, 15, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.27", "OutcomeMeasurementSpread":"0.79" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.30", "OutcomeMeasurementSpread":"1.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.73", "OutcomeMeasurementSpread":"0.96" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.25", "OutcomeMeasurementSpread":"1.06" } ] } } ] } },{ "OutcomeClassTitle":"4 hours (n=11, 10, 15, 10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.27", "OutcomeMeasurementSpread":"0.79" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.20", "OutcomeMeasurementSpread":"0.92" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.87", "OutcomeMeasurementSpread":"0.92" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.60", "OutcomeMeasurementSpread":"1.17" } ] } } ] } },{ "OutcomeClassTitle":"6 hours (n=11, 9, 15, 9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.64", "OutcomeMeasurementSpread":"0.67" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.67", "OutcomeMeasurementSpread":"0.87" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.87", "OutcomeMeasurementSpread":"0.92" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.11", "OutcomeMeasurementSpread":"0.78" } ] } } ] } },{ "OutcomeClassTitle":"8 hours (n=10, 9, 15, 8)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.70", "OutcomeMeasurementSpread":"0.82" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.67", "OutcomeMeasurementSpread":"1.32" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.60", "OutcomeMeasurementSpread":"0.91" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.13", "OutcomeMeasurementSpread":"0.83" } ] } } ] } },{ "OutcomeClassTitle":"24 hours (n=8, 7, 8, 7)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.63", "OutcomeMeasurementSpread":"0.52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.86", "OutcomeMeasurementSpread":"0.38" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.38", "OutcomeMeasurementSpread":"0.74" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.71", "OutcomeMeasurementSpread":"0.49" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM (n=14, 16, 14, 16)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementSpread":"0.36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.25", "OutcomeMeasurementSpread":"0.58" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.50", "OutcomeMeasurementSpread":"0.65" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.25", "OutcomeMeasurementSpread":"0.45" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time-specific Pain Intensity Difference (PID) Score", "OutcomeMeasureDescription":"Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"15 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementSpread":"0.64" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementSpread":"0.65" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.18", "OutcomeMeasurementSpread":"0.39" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementSpread":"0.39" } ] } } ] } },{ "OutcomeClassTitle":"30 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.18", "OutcomeMeasurementSpread":"0.73" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.35", "OutcomeMeasurementSpread":"0.78" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.41", "OutcomeMeasurementSpread":"0.67" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.35", "OutcomeMeasurementSpread":"0.71" } ] } } ] } },{ "OutcomeClassTitle":"45 minutes (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementSpread":"0.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.30", "OutcomeMeasurementSpread":"0.88" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.59", "OutcomeMeasurementSpread":"0.67" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.35", "OutcomeMeasurementSpread":"0.83" } ] } } ] } },{ "OutcomeClassTitle":"1 hour (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementSpread":"0.64" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementSpread":"0.83" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.68", "OutcomeMeasurementSpread":"0.72" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.39", "OutcomeMeasurementSpread":"1.03" } ] } } ] } },{ "OutcomeClassTitle":"1.5 hours (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementSpread":"0.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.04", "OutcomeMeasurementSpread":"0.88" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.68", "OutcomeMeasurementSpread":"0.78" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.26", "OutcomeMeasurementSpread":"1.01" } ] } } ] } },{ "OutcomeClassTitle":"2 hours (n=15, 13, 20, 16)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.13", "OutcomeMeasurementSpread":"0.64" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.69", "OutcomeMeasurementSpread":"0.48" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.75", "OutcomeMeasurementSpread":"0.97" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.44", "OutcomeMeasurementSpread":"0.96" } ] } } ] } },{ "OutcomeClassTitle":"3 hours (n=11, 10, 15, 12)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.82", "OutcomeMeasurementSpread":"0.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementSpread":"0.67" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementSpread":"0.68" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.83", "OutcomeMeasurementSpread":"0.94" } ] } } ] } },{ "OutcomeClassTitle":"4 hours (n=11, 10, 15, 10)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementSpread":"0.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.90", "OutcomeMeasurementSpread":"0.57" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementSpread":"0.56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementSpread":"0.63" } ] } } ] } },{ "OutcomeClassTitle":"6 hours (n=11, 9, 15, 9)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.91", "OutcomeMeasurementSpread":"0.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.22", "OutcomeMeasurementSpread":"0.44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementSpread":"0.68" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.44", "OutcomeMeasurementSpread":"0.53" } ] } } ] } },{ "OutcomeClassTitle":"8 hours (n=10, 9, 15, 8)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementSpread":"0.47" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.22", "OutcomeMeasurementSpread":"0.67" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementSpread":"0.56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.50", "OutcomeMeasurementSpread":"0.76" } ] } } ] } },{ "OutcomeClassTitle":"24 hours (n=8, 7, 8, 7)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.63", "OutcomeMeasurementSpread":"0.52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.86", "OutcomeMeasurementSpread":"0.38" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.63", "OutcomeMeasurementSpread":"0.74" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.86", "OutcomeMeasurementSpread":"0.69" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM (n=14, 16, 14, 16)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.57", "OutcomeMeasurementSpread":"0.51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.44", "OutcomeMeasurementSpread":"0.51" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.29", "OutcomeMeasurementSpread":"0.61" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.50", "OutcomeMeasurementSpread":"0.52" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours", "OutcomeMeasureDescription":"Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale*hour", "OutcomeMeasureTimeFrame":"0 to 6, 0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"SPID 0-6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9", "OutcomeMeasurementSpread":"1.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.0", "OutcomeMeasurementSpread":"1.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.1", "OutcomeMeasurementSpread":"1.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.4", "OutcomeMeasurementSpread":"1.1" } ] } } ] } },{ "OutcomeClassTitle":"SPID 0-24", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.7", "OutcomeMeasurementSpread":"5.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.6", "OutcomeMeasurementSpread":"5.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"13.3", "OutcomeMeasurementSpread":"5.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.7", "OutcomeMeasurementSpread":"5.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-0.4", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.8", "OutcomeAnalysisCIUpperLimit":"1.9", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.4" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-0.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.7", "OutcomeAnalysisCIUpperLimit":"2.0", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.4" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"2.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.4", "OutcomeAnalysisCIUpperLimit":"5.1", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"1.4" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-1.0", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-12.6", "OutcomeAnalysisCIUpperLimit":"10.5", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"7.0" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-0.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-11.5", "OutcomeAnalysisCIUpperLimit":"11.4", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"6.9" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"7.6", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-4.0", "OutcomeAnalysisCIUpperLimit":"19.1", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"7.0" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Total Pain Relief (TOTPAR) Score From 0 to 24 Hours", "OutcomeMeasureDescription":"TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Least Squares Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"units on a scale*hour", "OutcomeMeasureTimeFrame":"0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21.8", "OutcomeMeasurementSpread":"7.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.7", "OutcomeMeasurementSpread":"7.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"30.8", "OutcomeMeasurementSpread":"7.4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"21.5", "OutcomeMeasurementSpread":"7.3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"0.2", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-15.6", "OutcomeAnalysisCIUpperLimit":"16.1", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"9.5" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"-0.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-16.5", "OutcomeAnalysisCIUpperLimit":"14.8", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"9.4" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"LS mean difference", "OutcomeAnalysisParamValue":"9.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-6.6", "OutcomeAnalysisCIUpperLimit":"25.1", "OutcomeAnalysisDispersionType":"Standard Error of the mean", "OutcomeAnalysisDispersionValue":"9.5" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Onset of First Perceptible Pain Relief (PR)", "OutcomeMeasureDescription":"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.3", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"0.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.3", "OutcomeMeasurementUpperLimit":"0.5" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.8", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.5", "OutcomeAnalysisCIUpperLimit":"1.5" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.2", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.7", "OutcomeAnalysisCIUpperLimit":"2.1" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.1", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.6", "OutcomeAnalysisCIUpperLimit":"2.0" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Onset of First Meaningful Pain Relief (PR)", "OutcomeMeasureDescription":"Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.0", "OutcomeMeasurementLowerLimit":"2.5", "OutcomeMeasurementUpperLimit":"5.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementLowerLimit":"2.0", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.3", "OutcomeMeasurementLowerLimit":"1.0", "OutcomeMeasurementUpperLimit":"4.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.5", "OutcomeMeasurementLowerLimit":"2.8", "OutcomeMeasurementUpperLimit":"4.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.0", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.5", "OutcomeAnalysisCIUpperLimit":"2.1" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.9", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.4", "OutcomeAnalysisCIUpperLimit":"1.8" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.5", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.7", "OutcomeAnalysisCIUpperLimit":"2.9" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to First Use of Rescue Medication", "OutcomeMeasureDescription":"Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"90% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"1.5 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.8", "OutcomeMeasurementLowerLimit":"1.8", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.6", "OutcomeMeasurementLowerLimit":"1.7", "OutcomeMeasurementUpperLimit":"10.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11.1", "OutcomeMeasurementLowerLimit":"2.4", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.2", "OutcomeMeasurementLowerLimit":"2.0", "OutcomeMeasurementUpperLimit":"12.9" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.0", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.6", "OutcomeAnalysisCIUpperLimit":"1.9" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"1.3", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.7", "OutcomeAnalysisCIUpperLimit":"2.4" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.7", "OutcomeAnalysisCIPctValue":"90", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.4", "OutcomeAnalysisCIUpperLimit":"1.3" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Rescue Medication", "OutcomeMeasureDescription":"Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"0 to 24 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Participant Global Evaluation of Study Medication", "OutcomeMeasureDescription":"Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6, 24 hours, prior to RM", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"6 hours: Excellent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"6 hours: Very Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"6 hours: Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"6 hours: Fair", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours: Poor", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Excellent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Very Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Fair", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Poor", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM: Excellent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM: Very Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM: Good", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM: Fair", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM: Poor", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Participant Satisfaction Questionnaire", "OutcomeMeasureDescription":"Participant's response to 2 questions about \"how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)\" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.", "OutcomeMeasurePopulationDescription":"FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6, 24 hours, prior to RM", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"6 hours PR: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"6 hours PR: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"6 hours PR: Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"6 hours PR: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours PR: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours PR: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"6 hours OP: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours PR: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"24 hours OP: Not Done", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, PR: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, PR: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, PR:Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, PR: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, PR: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, OP: Very Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, OP: Somewhat Satisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, OP:Neither Satisfied nor Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, OP: Somewhat Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Prior to RM, OP: Very Dissatisfied", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Maximum Observed Plasma Concentration (Cmax) of PF-04531083", "OutcomeMeasurePopulationDescription":"Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"nanogram per milliliter (ng/mL)", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5761", "OutcomeMeasurementSpread":"1905.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9433", "OutcomeMeasurementSpread":"3527.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.02", "OutcomeMeasurementLowerLimit":"1.02", "OutcomeMeasurementUpperLimit":"6.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.00", "OutcomeMeasurementLowerLimit":"2.02", "OutcomeMeasurementUpperLimit":"24.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083", "OutcomeMeasureDescription":"AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"nanogram*hour per milliliter (ng*hr/mL)", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21920", "OutcomeMeasurementSpread":"7707.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"34640", "OutcomeMeasurementSpread":"16408.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083", "OutcomeMeasureDescription":"AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ng*hr/mL", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"80140", "OutcomeMeasurementSpread":"23571" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"147100", "OutcomeMeasurementSpread":"49215" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Maximum Observed Plasma Concentration (Cmax) of Ibuprofen", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"microgram per milliliter (mcg/mL)", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"(R)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.93", "OutcomeMeasurementSpread":"4.6191" } ] } } ] } },{ "OutcomeClassTitle":"(S)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12.10", "OutcomeMeasurementSpread":"3.7848" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"hours", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"(R)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.02", "OutcomeMeasurementLowerLimit":"1.00", "OutcomeMeasurementUpperLimit":"24.1" } ] } } ] } },{ "OutcomeClassTitle":"(S)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.02", "OutcomeMeasurementLowerLimit":"1.02", "OutcomeMeasurementUpperLimit":"6.23" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen", "OutcomeMeasureDescription":"AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"microgram*hour per milliliter (mcg*h/mL)", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"(R)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.39", "OutcomeMeasurementSpread":"12.847" } ] } } ] } },{ "OutcomeClassTitle":"(S)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.72", "OutcomeMeasurementSpread":"13.070" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen", "OutcomeMeasureDescription":"AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.", "OutcomeMeasurePopulationDescription":"PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mcg*hr/mL", "OutcomeMeasureTimeFrame":"0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"(R)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56.82", "OutcomeMeasurementSpread":"49.272" } ] } } ] } },{ "OutcomeClassTitle":"(S)-Ibuprofen", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"82.58", "OutcomeMeasurementSpread":"47.992" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)", "OutcomeMeasureDescription":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline up to Day 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"AEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9" } ] } } ] } },{ "OutcomeClassTitle":"SAEs", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Clinically Significant Laboratory Test Abnormality", "OutcomeMeasureDescription":"Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Baseline up to Day 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Supine Systolic and Diastolic Blood Pressure (BP)", "OutcomeMeasureDescription":"Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmHg", "OutcomeMeasureTimeFrame":"Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Screening: Systolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"124.3", "OutcomeMeasurementSpread":"9.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"123.2", "OutcomeMeasurementSpread":"9.62" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"122.4", "OutcomeMeasurementSpread":"10.05" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"126.5", "OutcomeMeasurementSpread":"10.22" } ] } } ] } },{ "OutcomeClassTitle":"Screening: Diastolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"71.4", "OutcomeMeasurementSpread":"8.75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"69.7", "OutcomeMeasurementSpread":"6.33" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"71.4", "OutcomeMeasurementSpread":"6.99" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"72.8", "OutcomeMeasurementSpread":"8.31" } ] } } ] } },{ "OutcomeClassTitle":"Day 0: Systolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"128.2", "OutcomeMeasurementSpread":"14.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"122.4", "OutcomeMeasurementSpread":"10.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"126.7", "OutcomeMeasurementSpread":"11.15" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"128.0", "OutcomeMeasurementSpread":"10.80" } ] } } ] } },{ "OutcomeClassTitle":"Day 0: Diastolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"71.8", "OutcomeMeasurementSpread":"10.52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"71.1", "OutcomeMeasurementSpread":"6.68" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"71.6", "OutcomeMeasurementSpread":"6.75" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"71.3", "OutcomeMeasurementSpread":"9.10" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: Systolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"122.8", "OutcomeMeasurementSpread":"12.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"126.8", "OutcomeMeasurementSpread":"13.17" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"126.6", "OutcomeMeasurementSpread":"14.40" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"124.1", "OutcomeMeasurementSpread":"14.39" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: Diastolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"67.2", "OutcomeMeasurementSpread":"8.89" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"71.1", "OutcomeMeasurementSpread":"9.59" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"72.5", "OutcomeMeasurementSpread":"9.61" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"70.7", "OutcomeMeasurementSpread":"11.51" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: Systolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"121.2", "OutcomeMeasurementSpread":"10.51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"119.3", "OutcomeMeasurementSpread":"10.52" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"124.0", "OutcomeMeasurementSpread":"11.39" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"122.2", "OutcomeMeasurementSpread":"12.31" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: Diastolic BP (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"65.9", "OutcomeMeasurementSpread":"9.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.3", "OutcomeMeasurementSpread":"7.07" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"67.7", "OutcomeMeasurementSpread":"8.90" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"69.6", "OutcomeMeasurementSpread":"8.48" } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"122.8", "OutcomeMeasurementSpread":"11.05" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"124.9", "OutcomeMeasurementSpread":"10.70" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"125.4", "OutcomeMeasurementSpread":"11.14" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"122.5", "OutcomeMeasurementSpread":"10.18" } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"69.7", "OutcomeMeasurementSpread":"11.32" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"70.6", "OutcomeMeasurementSpread":"9.66" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"72.1", "OutcomeMeasurementSpread":"5.56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"72.3", "OutcomeMeasurementSpread":"9.83" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)", "OutcomeMeasureDescription":"Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"milliseconds", "OutcomeMeasureTimeFrame":"Screening, Day 1, 2, 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Screening: PR Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"157.1", "OutcomeMeasurementSpread":"27.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"156.0", "OutcomeMeasurementSpread":"20.64" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"150.7", "OutcomeMeasurementSpread":"23.17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"156.4", "OutcomeMeasurementSpread":"22.12" } ] } } ] } },{ "OutcomeClassTitle":"Screening: QRS Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"90.3", "OutcomeMeasurementSpread":"8.33" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"95.8", "OutcomeMeasurementSpread":"9.96" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"93.2", "OutcomeMeasurementSpread":"8.74" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"93.7", "OutcomeMeasurementSpread":"8.68" } ] } } ] } },{ "OutcomeClassTitle":"Screening: QT Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"398.4", "OutcomeMeasurementSpread":"34.27" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"413.2", "OutcomeMeasurementSpread":"34.29" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"410.7", "OutcomeMeasurementSpread":"25.43" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"410.3", "OutcomeMeasurementSpread":"26.56" } ] } } ] } },{ "OutcomeClassTitle":"Screening: QTcF Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"399.8", "OutcomeMeasurementSpread":"16.34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"403.6", "OutcomeMeasurementSpread":"18.33" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"400.9", "OutcomeMeasurementSpread":"16.33" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"404.0", "OutcomeMeasurementSpread":"17.03" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: PR Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"154.2", "OutcomeMeasurementSpread":"21.51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"148.7", "OutcomeMeasurementSpread":"18.71" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"148.4", "OutcomeMeasurementSpread":"23.81" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"152.5", "OutcomeMeasurementSpread":"14.93" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: QRS Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"89.7", "OutcomeMeasurementSpread":"7.15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"95.0", "OutcomeMeasurementSpread":"9.96" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"91.5", "OutcomeMeasurementSpread":"7.90" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"90.8", "OutcomeMeasurementSpread":"8.96" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: QT Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"372.0", "OutcomeMeasurementSpread":"18.27" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"391.1", "OutcomeMeasurementSpread":"27.39" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"388.7", "OutcomeMeasurementSpread":"28.41" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"388.9", "OutcomeMeasurementSpread":"28.00" } ] } } ] } },{ "OutcomeClassTitle":"Day 1: QTcF Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"388.5", "OutcomeMeasurementSpread":"15.48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"393.4", "OutcomeMeasurementSpread":"18.82" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"395.3", "OutcomeMeasurementSpread":"17.66" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"398.7", "OutcomeMeasurementSpread":"15.14" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: PR Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"156.9", "OutcomeMeasurementSpread":"22.83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"149.1", "OutcomeMeasurementSpread":"17.79" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"150.8", "OutcomeMeasurementSpread":"22.86" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"153.9", "OutcomeMeasurementSpread":"18.33" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: QRS Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"87.6", "OutcomeMeasurementSpread":"7.63" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"93.7", "OutcomeMeasurementSpread":"8.10" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"88.5", "OutcomeMeasurementSpread":"11.73" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"90.4", "OutcomeMeasurementSpread":"8.38" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: QT Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"381.1", "OutcomeMeasurementSpread":"24.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"395.5", "OutcomeMeasurementSpread":"32.99" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"385.8", "OutcomeMeasurementSpread":"32.91" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"396.7", "OutcomeMeasurementSpread":"26.22" } ] } } ] } },{ "OutcomeClassTitle":"Day 2: QTcF Interval (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"394.0", "OutcomeMeasurementSpread":"14.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"397.9", "OutcomeMeasurementSpread":"18.87" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"396.6", "OutcomeMeasurementSpread":"19.03" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"404.2", "OutcomeMeasurementSpread":"16.82" } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"148.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Standard deviation was not estimable since only 1 participant was evaluable." } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"102.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Standard deviation was not estimable since only 1 participant was evaluable." } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"360.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Standard deviation was not estimable since only 1 participant was evaluable." } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"401.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Standard deviation was not estimable since only 1 participant was evaluable." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)", "OutcomeMeasureDescription":"Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"beats per minute", "OutcomeMeasureTimeFrame":"Screening, Day 1, 2, 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Screening (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"62.2", "OutcomeMeasurementSpread":"11.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"57.1", "OutcomeMeasurementSpread":"10.02" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"56.5", "OutcomeMeasurementSpread":"8.05" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"58.0", "OutcomeMeasurementSpread":"8.54" } ] } } ] } },{ "OutcomeClassTitle":"Day 1 (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"69.1", "OutcomeMeasurementSpread":"10.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.7", "OutcomeMeasurementSpread":"7.08" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"64.0", "OutcomeMeasurementSpread":"9.51" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"65.8", "OutcomeMeasurementSpread":"10.89" } ] } } ] } },{ "OutcomeClassTitle":"Day 2 (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"67.2", "OutcomeMeasurementSpread":"9.83" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"62.5", "OutcomeMeasurementSpread":"11.60" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"66.3", "OutcomeMeasurementSpread":"10.09" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"64.3", "OutcomeMeasurementSpread":"8.26" } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up) (n=0, 0, 0, 1)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"NA", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs." },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"83.0", "OutcomeMeasurementSpread":"NA", "OutcomeMeasurementComment":"Standard deviation was not estimable since only 1 participant was evaluable." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Supine Pulse Rate", "OutcomeMeasureDescription":"Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"beats per minute", "OutcomeMeasureTimeFrame":"Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"PF-04531083 1000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"PF-04531083 2000 mg", "OutcomeGroupDescription":"Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Ibuprofen 400 mg", "OutcomeGroupDescription":"Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Screening (n=22, 23, 22, 23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.1", "OutcomeMeasurementSpread":"13.08" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"56.2", "OutcomeMeasurementSpread":"10.48" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"55.1", "OutcomeMeasurementSpread":"7.97" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"57.0", "OutcomeMeasurementSpread":"10.45" } ] } } ] } },{ "OutcomeClassTitle":"Day 0 (n=22,23,22,23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61.6", "OutcomeMeasurementSpread":"8.56" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.3", "OutcomeMeasurementSpread":"9.89" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"62.1", "OutcomeMeasurementSpread":"10.23" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"63.1", "OutcomeMeasurementSpread":"12.40" } ] } } ] } },{ "OutcomeClassTitle":"Day 1 (n=22,23,22,23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"66.4", "OutcomeMeasurementSpread":"10.06" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59.5", "OutcomeMeasurementSpread":"8.81" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.2", "OutcomeMeasurementSpread":"7.32" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"59.4", "OutcomeMeasurementSpread":"9.48" } ] } } ] } },{ "OutcomeClassTitle":"Day 2 (n=22,23,22,23)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"64.1", "OutcomeMeasurementSpread":"9.59" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"60.6", "OutcomeMeasurementSpread":"12.03" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"65.9", "OutcomeMeasurementSpread":"8.71" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"62.7", "OutcomeMeasurementSpread":"8.55" } ] } } ] } },{ "OutcomeClassTitle":"Day 10-14 (Follow-up) (n=21, 23, 22, 22)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61.3", "OutcomeMeasurementSpread":"9.91" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"60.4", "OutcomeMeasurementSpread":"10.60" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"59.6", "OutcomeMeasurementSpread":"11.81" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"62.0", "OutcomeMeasurementSpread":"8.91" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsDescription":"The same event may appear as both an AE and a SAE. However, what is presented are distinct events. 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"AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results." }, "PointOfContact":{ "PointOfContactTitle":"Pfizer ClinicalTrials.gov Call Center", "PointOfContactOrganization":"Pfizer, Inc.", "PointOfContactEMail":"ClinicalTrials.gov_Inquiries@pfizer.com", "PointOfContactPhone":"1-800-718-1021" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007052", "InterventionMeshTerm":"Ibuprofen" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory 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