{ "FullStudy":{ "Rank":218007, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513967", "OrgStudyIdInfo":{ "OrgStudyId":"RGN-ADC-001" }, "Organization":{ "OrgFullName":"Regenera Pharma Ltd", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease", "OfficialTitle":"A Randomized Single and Multiple Dose Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease" }, "StatusModule":{ "StatusVerifiedDate":"March 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 18, 2018", "ResultsFirstSubmitQCDate":"March 9, 2020", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 23, 2020", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"March 9, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 23, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Regenera Pharma Ltd", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Syneos Health", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)", "DetailedDescription":"The primary objective of this study is to evaluate the safety and tolerability of RPh201 after single and multiple ascending doses. This study is designed with sufficient time in between dose escalations to allow for an interim analysis of safety and tolerability data as this is considered the safest approach to assess the effects of a compound with an undefined mechanism and therapeutic target.\n\nThis protocol is written with some flexibility to accommodate the inherent dynamic nature of Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently outlined below may be required to achieve the scientific goals of the study objectives and/or to ensure appropriate safety monitoring of the study subjects. Interim safety analyses will guide dose escalation/reduction in the trial." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy Volunteers", "Moderate to Severe Alzheimer Patients" ] }, "KeywordList":{ "Keyword":[ "Alzheimer,", "dementia" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"39", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Part A, SAD Treatment 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 single dose (SAD Low Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part A, SAD Placebo 1", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo single dose (SAD Low Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Part A, SAD Treatment 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 single dose (SAD Mid Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part A, SAD Placebo 2", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo single dose (SAD Mid Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Part A, SAD Treatment 3", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 single dose (SAD High Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part A, SAD Placebo 3", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo single dose (SAD High Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Part B, MAD Treatment 1", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 multiple dose (MAD Low Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part B, MAD Placebo 1", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo multiple dose (MAD Low Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Part B, MAD Treatment 2", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 multiple dose (MAD Mid Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part B, MAD Placebo 2", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo multiple dose (MAD Mid Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } },{ "ArmGroupLabel":"Part B, MAD Treatment 3", "ArmGroupType":"Experimental", "ArmGroupDescription":"RPh201 multiple dose (MAD High Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: RPh201, botanical drug product" ] } },{ "ArmGroupLabel":"Part B, MAD Placebo 3", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Placebo multiple dose (MAD High Dose )", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"RPh201, botanical drug product", "InterventionDescription":"SC administration at varying doses", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A, SAD Treatment 1", "Part A, SAD Treatment 2", "Part A, SAD Treatment 3", "Part B, MAD Treatment 1", "Part B, MAD Treatment 2", "Part B, MAD Treatment 3" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"SC administration at varying doses", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Part A, SAD Placebo 1", "Part A, SAD Placebo 2", "Part A, SAD Placebo 3", "Part B, MAD Placebo 1", "Part B, MAD Placebo 2", "Part B, MAD Placebo 3" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses.", "PrimaryOutcomeDescription":"Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events", "PrimaryOutcomeTimeFrame":"up to 1 month" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"For PART A AND PART B (healthy volunteers, SAD and MAD)\n\nInclusion Criteria:\n\nhealthy male or female subjects 18 to 65 years of age, inclusive\nbody mass index (BMI) within the range of 18.0 to 33.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg at Screening\nfemale subjects of childbearing potential must be practicing abstinence or using and willing to continue using two medically acceptable form of birth control for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include oral or patch hormonal contraceptives, intrauterine device, progestin implant or injection, bilateral tubal ligation, or double-barrier (i.e., male condom in addition to a diaphragm or a contraceptive sponge).\nfemale subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy/salpingo-oophorectomy (as determined by subject medical history)\nmale subjects of reproductive potential with a partner(s) of childbearing potential, must be using and willing to continue to using two medically acceptable contraceptive precautions from Screening and for at least 1 month after the last study drug administration. Medically acceptable forms of contraception include abstinence, vasectomy, or male condom for subjects\nfemale subjects must have a negative pregnancy test\nable to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments\nmust understand and provide written informed consent prior to the initiation of any protocol-specific procedures\nmust be willing and able to abide by all study requirements and restrictions\n\nExclusion Criteria:\n\ncurrent drug or alcohol dependence (excluding caffeine), based on self-report, including subjects who have been in a drug rehabilitation program\ncurrent smoker or a history of using tobacco products within 3 months prior to Screening\nclinically significant abnormalities on physical examination, medical history, 12-lead ECG (i.e., QTc > 440 for male subjects and > 450 for female subjects), vital signs, or laboratory values, as judged by the investigator or designee\nhistory or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results\nuse of a non-prescription drug within 7 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity or compromise the safety of the subject\nuse of any prescription medications, recreational drugs, or natural health products (except vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 14 days prior to first drug administration or throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject\npositive urine drug screen\npositive breath alcohol test. If a subject presents with positive breath alcohol test, the subject may be rescheduled at the discretion of the investigator or designee\nfemale subjects who are currently pregnant or lactating or who are planning to become pregnant within 60 days of last study drug administration\nhistory of allergy or hypersensitivity to mastic or related drugs (e.g., mastic gum, mastic resin, Chios mastic powder, retsina wine, Mastic Gum 500, Mastic Gum Elma 50, Nutricology Mastic Gum)\nhistory of allergy or hypersensitivity to cottonseed oil\npositive for Hepatitis B, Hepatitis C, or HIV\ncurrent or pending legal charges or currently on probation\ntreatment with any investigational drug within 30 days prior to first drug administration in the treatment phase\na subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason\n\nFor PART C (subjects with Alzheimer's Disease)\n\nInclusion Criteria:\n\nmales and females ages ≥ 55 years of age at Screening visit\ndiagnosis of AD, consistent with criteria from both the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Criteria for Probable AD and Diagnostic and Statistical Manual of Mental Disorders - IV TR (DSM-IV TR) Criteria for Dementia of the Alzheimer's Type\nMini-Mental Status Evaluation (MMSE) score of 5-15, inclusive, at Screening visit\nRosen-Modified Hachninski Ischemia score of ≤ 4 at Screening visit\nsubjects and caregivers must be able to read, write, and speak the language in which psychometric tests are provided with acceptable visual and auditory acuity\nsubject must have a reliable informant (caregiver) to provide collateral history and who will facilitate the subject's full participation in the study\nsubject and caregivers must provide written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures\nsubjects may continue on background cholinesterase inhibitor and/or memantine\nsubjects must be in satisfactory good health, in the opinion of the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests\nmagnetic resonance imaging (MRI) or computed tomography (CT) within 12 months of Screening visit consistent with a diagnosis of Probable AD without any other clinically significant findings\n\nExclusion Criteria:\n\ndiagnosis or history of other dementia or neurodegenerative disorders causing cognitive impairment (e.g., Parkinson's disease, Lewy body disease, Fronto-temporal Dementia, alcohol and drug abuse, Traumatic Brain Injury).\nsubjects receiving immunosuppressants, tricyclic anti-depressants, anticoagulants, or chemotherapeutic agents\nhypertension not adequately controlled, per investigator's judgment\npoorly controlled Type 1 and/or Type 2 diabetes, per investigator's judgment\nwomen of child bearing potential who are not using an effective method of birth control\nany other medical condition or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or that may interfere with the interpretation of study results, and that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Janice Faulknor, MD", "OverallOfficialAffiliation":"Kendle Early Stage - Toronto", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Sharon Cohen, MD", "OverallOfficialAffiliation":"Toronto Memory Program", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Toronto Memory Program", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M3B 2S7", "LocationCountry":"Canada" },{ "LocationFacility":"Kendle Early Stage - Toronto", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M5V 2T3", "LocationCountry":"Canada" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"31250992", "ReferenceType":"result", "ReferenceCitation":"Hazan Z, Adamsky K, Lucassen A, Levin LA. A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Jun 28. doi: 10.1002/cpdd.720. [Epub ahead of print]" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Part A, SAD Treatment 1 5mg", "FlowGroupDescription":"RPh201 single dose (SAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Part A, SAD Treatment 2", "FlowGroupDescription":"RPh201 single dose (SAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Part A, SAD Treatment 3", "FlowGroupDescription":"RPh201 single dose (SAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Part A, SAD Placebo", "FlowGroupDescription":"Placebo single dose (SAD 20mg)\n\nPlacebo: SC administration at varying doses" },{ "FlowGroupId":"FG004", "FlowGroupTitle":"Part B, MAD Treatment 1", "FlowGroupDescription":"RPh201 multiple dose (MAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG005", "FlowGroupTitle":"Part B, MAD Treatment 2", "FlowGroupDescription":"RPh201 multiple dose (MAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG006", "FlowGroupTitle":"Part B, MAD Treatment 3", "FlowGroupDescription":"RPh201 multiple dose (MAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "FlowGroupId":"FG007", "FlowGroupTitle":"Part B, MAD Placebo", "FlowGroupDescription":"Placebo multiple dose (MAD 20mg)\n\nPlacebo: SC administration at varying doses" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"8" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG004", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG005", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG006", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG007", "FlowAchievementNumSubjects":"2" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Pregnancy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"missed a study visit", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"excluded due to positive drug screen", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG004", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG005", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG006", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG007", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Part C of the study has not been initiated", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Part A, SAD Treatment 1 (5mg)", "BaselineGroupDescription":"RPh201 single dose (SAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Part A, SAD Treatment 2 (10mg)", "BaselineGroupDescription":"RPh201 single dose (SAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Part A, SAD Treatment 3 (20mg)", "BaselineGroupDescription":"RPh201 single dose (SAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Part A, SAD Placebo", "BaselineGroupDescription":"Placebo single dose (SAD)\n\nPlacebo: SC administration at varying doses" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Part B, MAD Treatment 1 (5mg)", "BaselineGroupDescription":"RPh201 multiple dose (MAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG005", "BaselineGroupTitle":"Part B, MAD Treatment 2 (10mg)", "BaselineGroupDescription":"RPh201 multiple dose (MAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG006", "BaselineGroupTitle":"Part B, MAD Treatment 3 (20mg)", "BaselineGroupDescription":"RPh201 multiple dose (MAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "BaselineGroupId":"BG007", "BaselineGroupTitle":"Part B, MAD Placebo", "BaselineGroupDescription":"Placebo multiple dose (MAD)\n\nPlacebo: SC administration at varying doses" },{ "BaselineGroupId":"BG008", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"6" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG005", "BaselineDenomCountValue":"4" },{ "BaselineDenomCountGroupId":"BG006", "BaselineDenomCountValue":"5" },{ "BaselineDenomCountGroupId":"BG007", "BaselineDenomCountValue":"8" },{ "BaselineDenomCountGroupId":"BG008", "BaselineDenomCountValue":"39" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"39" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"39.8", "BaselineMeasurementLowerLimit":"27", "BaselineMeasurementUpperLimit":"52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48.8", "BaselineMeasurementLowerLimit":"38", "BaselineMeasurementUpperLimit":"65" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"50.8", "BaselineMeasurementLowerLimit":"38", "BaselineMeasurementUpperLimit":"58" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"43.0", "BaselineMeasurementLowerLimit":"32", "BaselineMeasurementUpperLimit":"54" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"42.5", "BaselineMeasurementLowerLimit":"34", "BaselineMeasurementUpperLimit":"58" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"43.0", "BaselineMeasurementLowerLimit":"23", "BaselineMeasurementUpperLimit":"60" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"40.8", "BaselineMeasurementLowerLimit":"30", "BaselineMeasurementUpperLimit":"51" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"44.1", "BaselineMeasurementLowerLimit":"22", "BaselineMeasurementUpperLimit":"63" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"44.0", "BaselineMeasurementLowerLimit":"22", "BaselineMeasurementUpperLimit":"65" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"19" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG006", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG007", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG008", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ 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"BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67.7", "BaselineMeasurementLowerLimit":"64", "BaselineMeasurementUpperLimit":"74" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75.7", "BaselineMeasurementLowerLimit":"66", "BaselineMeasurementUpperLimit":"104" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"82.8", "BaselineMeasurementLowerLimit":"76", "BaselineMeasurementUpperLimit":"91" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"70.8", "BaselineMeasurementLowerLimit":"66", "BaselineMeasurementUpperLimit":"83" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"75.8", "BaselineMeasurementLowerLimit":"70", "BaselineMeasurementUpperLimit":"87" },{ "BaselineMeasurementGroupId":"BG005", "BaselineMeasurementValue":"62.2", "BaselineMeasurementLowerLimit":"59", 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included the following:\n\nRandomized Population: All subjects who were assigned a randomization number in the Treatment Phase.\n\nSafety Population: All randomized subjects who received any study treatment in the Treatment Phase.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"up to 1 month", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Part A, SAD Treatment 5mg", "OutcomeGroupDescription":"RPh201 single dose (SAD Low Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Part A, SAD Treatment 10mg", "OutcomeGroupDescription":"RPh201 single dose (SAD Mid Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Part A, SAD Treatment 20mg", "OutcomeGroupDescription":"RPh201 single dose (SAD High Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Part A, SAD Placebo", "OutcomeGroupDescription":"Placebo single dose (SAD High Dose )\n\nPlacebo: SC administration at varying doses" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Part B, MAD Treatment 5mg", "OutcomeGroupDescription":"RPh201 multiple dose (MAD Low Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Part B, MAD Treatment 10mg", "OutcomeGroupDescription":"RPh201 multiple dose (MAD Mid Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Part B, MAD Treatment 20mg", "OutcomeGroupDescription":"RPh201 multiple dose (MAD High Dose )\n\nRPh201, botanical drug product: SC administration at varying doses" },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Part B, MAD Placebo", "OutcomeGroupDescription":"Placebo multiple dose (MAD High Dose )\n\nPlacebo: SC administration at varying doses" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"6" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Subjects with TEAE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Subjects with SAE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Subjects with study drug discontinued due to AE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration.", "EventsDescription":"All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Part A, SAD Treatment 1 (5mg)", "EventGroupDescription":"RPh201 single dose (SAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG001", "EventGroupTitle":"Part A, SAD Treatment 2 (10mg)", "EventGroupDescription":"RPh201 single dose (SAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG002", "EventGroupTitle":"Part A, SAD Treatment 3 (20mg)", "EventGroupDescription":"RPh201 single dose (SAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG003", "EventGroupTitle":"Part A, SAD Placebo", "EventGroupDescription":"Placebo single dose (SAD)\n\nPlacebo: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"6", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"6" },{ "EventGroupId":"EG004", "EventGroupTitle":"Part B, MAD Treatment 1 (5mg)", "EventGroupDescription":"RPh201 multiple dose (MAD 5mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG005", "EventGroupTitle":"Part B, MAD Treatment 2 (10mg)", "EventGroupDescription":"RPh201 multiple dose (MAD 10mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG006", "EventGroupTitle":"Part B, MAD Treatment 3 (20mg)", "EventGroupDescription":"RPh201 multiple dose (MAD 20mg)\n\nRPh201, botanical drug product: SC administration at varying doses", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"5", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"5" },{ "EventGroupId":"EG007", "EventGroupTitle":"Part B, MAD Placebo", "EventGroupDescription":"Placebo multiple dose (MAD)\n\nPlacebo: SC administration at varying doses", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"8", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"8" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Pregnancy", "SeriousEventOrganSystem":"Pregnancy, puerperium and perinatal conditions", "SeriousEventSourceVocabulary":"MedDRA (15.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"6" },{ "SeriousEventStatsGroupId":"EG004", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG005", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG006", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"5" },{ "SeriousEventStatsGroupId":"EG007", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"8" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Lymphadenopathy", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA (15.0)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"4" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"4" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", 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