{ "FullStudy":{ "Rank":217559, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519817", "OrgStudyIdInfo":{ "OrgStudyId":"120056" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"12-C-0056" } ] }, "Organization":{ "OrgFullName":"National Institutes of Health Clinical Center (CC)", "OrgClass":"NIH" }, "BriefTitle":"Cancer Vaccine Targeting Brachyury Protein in Tumors", "OfficialTitle":"An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express Brachyury Protein in Adults With Solid Tumors" }, "StatusModule":{ "StatusVerifiedDate":"January 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 5, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 3, 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 1, 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 26, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 27, 2017", "ResultsFirstSubmitQCDate":"May 30, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 31, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"January 2, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 29, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"James Gulley, M.D.", "ResponsiblePartyInvestigatorTitle":"Senior Investigator", "ResponsiblePartyInvestigatorAffiliation":"National Cancer Institute (NCI)" }, "LeadSponsor":{ "LeadSponsorName":"National Cancer Institute (NCI)", "LeadSponsorClass":"NIH" } }, "OversightModule":{ "OversightHasDMC":"Yes", "IsFDARegulatedDrug":"Yes", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"Background:\n\n- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas.\n\nObjectives:\n\n- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells.\n\nEligibility:\n\nIndividuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments.\nBecause the vaccine is made with yeast, people with yeast allergies will not be eligible.\n\nDesign:\n\nParticipants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected.\nParticipants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month.\nTreatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study.\nParticipants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....", "DetailedDescription":"Background:\n\nVaccines based on recombinant heat inactivated yeast have been shown to be immunogenic and well tolerated in animals and humans.\nUsing a computer-based differential display analysis tool to conduct global comparison of expressed sequence tag (EST) clusters in the Unigene database, the gene encoding for the transcription factor Brachyury was identified as highly represented in tumor-derived libraries and rarely observed in normal tissue-derived libraries. By using reverse-transcription followed by polymerase chain reaction (RT-PCR), investigators in the LTIB have identified the overexpression of Brachyury in gastrointestinal, bladder, kidney, ovary, uterus, and testicular carcinomas. Similar studies also found over-expression of Brachyury mRNA in cell lines of lung, colon and prostate cancers, but not in the majority of normal tissues tested, with the exception of expression in the testis, thyroid and low levels of expression in B cells pooled from multiple normal donors.\nBrachyury is a member of the T-box family of transcription factors, characterized by a highly conserved DNA-binding domain designated as T-domain. Data indicates that the transcription factor Brachyury confers on the tumor cells a mesenchymal phenotype, as well as migratory and invasive abilities and enhances tumor cell progression.\nA murine model of MC38 cells engineered to over express human Brachyury gene has demonstrated increased metastatic potential of Brachyury over-expressing MC38 cells.\nBrachyury specific T cells can lyse human cancer cells expressing Brachyury in an MHC restricted manner.\nGI-6301 (Yeast-Brachyury vaccine) has been tested in vitro and in the mouse model. These studies showed Brachyury-specific T cell responses and decreased metastasis in mice treated with vaccine.\nAn ongoing study of a Hepatitis B vaccine (GS-4774) using the yeast platform (heat killed Saccharomyces cerevisiae) indicated safety of 80 YU dose (4 injection sites at 20 YU injections per site).\n\nObjectives:\n\n-The primary objectives are to:\n\nDetermine the safety and tolerability of escalating doses of GI-6301 (Yeast-Brachyury vaccine) a heat-killed yeast-based vaccine\nDetermine in an expanded cohort if a significant change in Brachyury specific T cells will be detectable post vaccine.\n\nEligibility:\n\nAdults with histologically proven metastatic or locally advanced solid tumors for which standard curative or palliative measures are no longer effective. Efforts will be made, as much as possible, to enroll patients with tumor types with known increased expression of Brachyury (such as lung, breast, ovarian, prostate, colorectal, pancreatic or chordoma).\nAdequate organ function as defined by liver, kidney, and hematologic laboratory testing.\nPatients with acquired immune defects, systemic autoimmune disease, concurrent use of steroids, pericardial mass > 1 cm, chronic infections, concurrent tricyclic antidepressant therapy, or allergy to yeast or yeast-based products will be excluded.\n\nDesign:\n\nThis is an open label, phase I trial with sequential dose escalation cohorts of patients (3-6 patients per dose cohort) for 3 doses of GI-6301 (Yeast-Brachyury vaccine).\nGI-6301 (Yeast-Brachyury vaccine) will be administered subcutaneously at 4 sites biweekly for 7 visits (day 1, 15, 29, 43, 57, 71, 85), then monthly until patients meet off-study criteria\n\n(patients who have been on study for one year or more and have had stable disease or better (PR, CR) have the option to receive vaccine once every 3 months instead of monthly).\n\nAll patients on a given dose level will have completed 28 days on-study without DLT before enrollment can begin on the next dose level or on the expansion phase (see statistical analysis section).\nExpansion Phase: 10 additional patients will be enrolled on the MTD dose level (or the highest dose level explored in the event that a true MTD is not reached), receiving the same treatment regimen, to assess for immunologic responses and clinical responses.\nAmended dose escalation: 10 patients will be enrolled at an additional dose level (80 YU per dose, 4 injection sites at 20 YU per site) to determine the safety of this dose level.\nUp to 33 total patients may be required to complete enrollment of this study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Neoplasms", "Malignant Solid Tumors", "Colon Neoplasms", "Adenocarcinoma" ] }, "KeywordList":{ "Keyword":[ "Vaccine Therapy", "Dose-Limiting Toxicity", "Maximum Tolerated Dose", "Clinical Response", "Immune Response", "Cancer", "Solid Tumor" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"34", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Yeast-Brachyury vaccine", "ArmGroupType":"Experimental", "ArmGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: GI-6301 (Yeast Brachyury Vaccine)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"GI-6301 (Yeast Brachyury Vaccine)", "InterventionDescription":"GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Yeast-Brachyury vaccine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Yeast-Brachyury vaccine" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Brachyury-Specific T-cell Responses", "PrimaryOutcomeDescription":"A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.", "PrimaryOutcomeTimeFrame":"Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)" },{ "PrimaryOutcomeMeasure":"Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine", "PrimaryOutcomeDescription":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.", "PrimaryOutcomeTimeFrame":"4 years and 25 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)", "SecondaryOutcomeDescription":"Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.", "SecondaryOutcomeTimeFrame":"3 and 5 months restaging" },{ "SecondaryOutcomeMeasure":"Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)", "SecondaryOutcomeDescription":"Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "SecondaryOutcomeTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations" },{ "SecondaryOutcomeMeasure":"Changes in Serum Levels of Cytokines", "SecondaryOutcomeDescription":"Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "SecondaryOutcomeTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations" },{ "SecondaryOutcomeMeasure":"Changes in Soluble Cluster of Differentiation 27 (sCD27)", "SecondaryOutcomeDescription":"Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "SecondaryOutcomeTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations" },{ "SecondaryOutcomeMeasure":"Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)", "SecondaryOutcomeDescription":"Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "SecondaryOutcomeTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations" },{ "SecondaryOutcomeMeasure":"Changes in Soluble Cluster of Differentiation 40L (sCD40L)", "SecondaryOutcomeDescription":"Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "SecondaryOutcomeTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"INCLUSION CRITERIA:\n\nParticipants must meet the following criteria for participation:\n\nDiagnosis: Patients must have histologically confirmed malignancy by the Laboratory of Pathology, National Cancer Institute (NCI), that is metastatic or unresectable locally advanced malignant solid tumor. In the case of Chordoma, unresectable, locally recurrent, or metastatic tumors are acceptable for enrollment, given that this represents incurable disease. Efforts will be made, as much as possible, to enroll patients with tumor types with known increased expression of Brachyury (such as lung, breast, ovarian, prostate, colorectal, pancreatic, or chordoma).\nPatients may have disease that is measurable or non-measurable but evaluable disease\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study entry (Karnofsky greater than or equal to 70)\nAge greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of Yeast Brachyury vaccine in patients <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\nPrior Therapy: Completed or had disease progression on at least one prior line of diseaseappropriate therapy for metastatic disease, or not be a candidate for therapy of proven efficacy for their disease.\n\nPatients must have normal organ and marrow function as defined below:\n\nSerum creatinine 1.5 times upper limit of normal OR creatinine clearance on a 24-h urine collection of 60 mL/min.\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 times the upper limits of normal.\nTotal bilirubin less than or equal to 1.5 times upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin 3.0.\nHematological eligibility parameters (within16 days of starting therapy):\nGranulocyte count 1,500/mm(3)\nPlatelet count 100,000/m(3)\nPatients must have baseline pulse oximetry > 90% on room air.\nRecovered completely (Grade 1 or baseline) from any reversible toxicity associated with recent therapy. Typically this is 3 4 weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery.\nThere should be a minimum of 2 weeks from any prior chemotherapy, immunotherapy and/or radiation.\nPrior immune therapy is allowed.\nMen and women of child-bearing potential must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.\nPatients with prostate cancer must continue to receive gonadotropin-releasing hormone (GnRH) agonist therapy (unless orchiectomy has been done). If a patient has refused GnRH therapy, they may be enrolled on a dose level for which the safety has already been determined.\nPatients with estrogen-receptor positive (ER+) breast cancer being treated with adjuvant hormonal therapy (selective estrogen receptor modulator or aromatase inhibitor) who have rising tumor markers as evidence of disease progression or metastatic disease on scans may continue on hormonal therapy while being treated with vaccine.\nPatients must be negative for yeast allergy skin test\nAbility to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nPatients with any of the following will not be eligible for participation in this study:\n\n- Patients should have no evidence of immune dysfunction as listed below.\n\nHuman immunodeficiency virus (HIV) positivity due to the potential for decreased immune response to the vaccine.\nActive autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. However, patients with vitiligo, diabetes mellitus, and hashimoto s thyroiditis on appropriate replacement therapy may be\n\nenrolled.\n\n--Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent intravenous (IV) contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.\n\nHistory of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).\nPregnant or breast-feeding women, due to the unknown effects of the Yeast Brachyury vaccine on the fetus or infant.\nSerious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.\nUntreated brain metastases (or local treatment of brain metastases within the last 6 months) and or spinal cord metastasis.\nPatients with pericardial masses >1 cm will be excluded.\nConcurrent chemotherapy. (However, the following anti-tumor therapies will be allowed: Trastuzumab for human epidermal growth factor receptor 2 (HER2+) breast cancer and hormonal therapy for breast (e.g., selective estrogen receptor modulators, aromatase inhibitors) and prostate cancer (e.g., GnRH antagonists/agonists or antagonists and androgen receptor antagonists).\nChronic hepatitis infection, including B and C, because potential immune impairment caused by these disorders may diminish the effectiveness of this immunologic therapy.\nPatients requiring continuous tricyclic antidepressant therapy should be excluded due to the interference with the yeast skin test in creating false negative test results.\nParticipation in another interventional clinical trial within 28 days before start of study treatment.\nAny significant disease that, in the opinion of the investigator, may impair the patient s tolerance of study treatment.\nSignificant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"100 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"James L Gulley, M.D.", "OverallOfficialAffiliation":"National Cancer Institute (NCI)", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"National Institutes of Health Clinical Center, 9000 Rockville Pike", "LocationCity":"Bethesda", "LocationState":"Maryland", "LocationZip":"20892", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"11707285", "ReferenceType":"background", "ReferenceCitation":"Baranova AV, Lobashev AV, Ivanov DV, Krukovskaya LL, Yankovsky NK, Kozlov AP. In silico screening for tumour-specific expressed sequences in human genome. FEBS Lett. 2001 Nov 9;508(1):143-8." },{ "ReferencePMID":"15741768", "ReferenceType":"background", "ReferenceCitation":"Krukovskaja LL, Baranova A, Tyezelova T, Polev D, Kozlov AP. Experimental study of human expressed sequences newly identified in silico as tumor specific. Tumour Biol. 2005 Jan-Feb;26(1):17-24. Epub 2005 Feb 28." },{ "ReferencePMID":"17438107", "ReferenceType":"background", "ReferenceCitation":"Palena C, Polev DE, Tsang KY, Fernando RI, Litzinger M, Krukovskaya LL, Baranova AV, Kozlov AP, Schlom J. The human T-box mesodermal transcription factor Brachyury is a candidate target for T-cell-mediated cancer immunotherapy. Clin Cancer Res. 2007 Apr 15;13(8):2471-8." },{ "ReferencePMID":"26130065", "ReferenceType":"result", "ReferenceCitation":"Heery CR, Singh BH, Rauckhorst M, Marté JL, Donahue RN, Grenga I, Rodell TC, Dahut W, Arlen PM, Madan RA, Schlom J, Gulley JL. Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury. Cancer Immunol Res. 2015 Nov;3(11):1248-56. doi: 10.1158/2326-6066.CIR-15-0119. Epub 2015 Jun 30." },{ "ReferencePMID":"26596767", "ReferenceType":"derived", "ReferenceCitation":"Fenerty KE, Patronas NJ, Heery CR, Gulley JL, Folio LR. Resources Required for Semi-Automatic Volumetric Measurements in Metastatic Chordoma: Is Potentially Improved Tumor Burden Assessment Worth the Time Burden? J Digit Imaging. 2016 Jun;29(3):357-64. doi: 10.1007/s10278-015-9846-9." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"NIH Clinical Center Detailed Web Page", "SeeAlsoLinkURL":"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2012-C-0056.html" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"4 YU (Dose Level 1)", "FlowGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"16 YU (Dose Level 2)", "FlowGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"40 YU (Dose Level 3)", "FlowGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"80 YU (Dose Level 4)", "FlowGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"11" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"10" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Off study due to infection", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"All Participants", "BaselineGroupDescription":"All participants who received at least one dose of 4YU, 16YU, 40YU or 80YU.\n\nYeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.\n\nGI-6301 (Yeast Brachyury Vaccine): GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"34" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58", "BaselineMeasurementLowerLimit":"32", "BaselineMeasurementUpperLimit":"79" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Hispanic or Latino", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"Not Hispanic or Latino", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"33" } ] } } ] } },{ "BaselineClassTitle":"Mexican, Puerto Rican, Cuban Central or So. Americ", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Eastern Cooperative Oncology Group (ECOG) Performance Status", "BaselineMeasureDescription":"ECOG: 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and bale to carry out work of a light or sedentary nature (e.g., light housework, office work).", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"0", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" } ] } },{ "BaselineCategoryTitle":"1", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Tumor Type", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"34" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Colorectal", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } },{ "BaselineCategoryTitle":"Chordoma", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } },{ "BaselineCategoryTitle":"Breast", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } },{ "BaselineCategoryTitle":"Pancreatic", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"Prostate", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Urothelial", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Lung", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Disease at Study Entry", "BaselineMeasureDescription":"Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response (≥30% decrease in the sum of greatest diameters; no new lesions), or progressive disease. Progressive disease is ≥20% increase in the sum of greatest diameters; new lesions.", "BaselineMeasurePopulationDescription":"23 participants with carcinomas (solid tumors) and 11 participants with chordomas.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Carcinomas", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"23" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Stable disease", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Progressive disease", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" } ] } } ] } },{ "BaselineClassTitle":"Chordomas", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Stable disease", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Progressive disease", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Prior Cytotoxic Regimens", "BaselineMeasureDescription":"Cytotoxic (i.e. poisonous to cancer cells)", "BaselineMeasurePopulationDescription":"The module refers to 23 participants with carcinomas (solid tumors).", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"0", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"23" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"1 regimen", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"23" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"2 regimens", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"23" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"≥3 regimens", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"23" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Tumor Anatomical Location", "BaselineMeasureDescription":"Sacral (i.e., sacrum), spinal (i.e., backbone), and clival (i.e. base of skull).", "BaselineMeasurePopulationDescription":"The module refers to 11 participants with chordomas.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Sacral", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } } ] } },{ "BaselineClassTitle":"Clival", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Spinal", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Prior Therapy", "BaselineMeasureDescription":"Surgery, radiotherapy and systemic therapy use surgical procedures, targeted therapy with radiation, steroids, and/or other immunosuppressive agents in an attempt to suppress one or more growing lesions.", "BaselineMeasurePopulationDescription":"The module refers to 11 participants with chordomas.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Surgery", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } } ] } },{ "BaselineClassTitle":"Radiotherapy", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" } ] } } ] } },{ "BaselineClassTitle":"Systemic therapy", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"11" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Brachyury-Specific T-cell Responses", "OutcomeMeasureDescription":"A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.", "OutcomeMeasurePopulationDescription":"Sufficient peripheral blood mononuclear cells (PBMCs) were available before and after vaccination from 31 of 34 patients to analyze brachyury-specific CD4 and CD8 T-cell responses.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"CD107a + CD4 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"IFN gamma + CD4 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"IL2 + CD4 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"TNF alpha + CD4 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"CD107a + CD8 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"IFN gamma + CD8 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"IL2 + CD8 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"TNF alpha + CD8 T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Any T-cell response", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine", "OutcomeMeasureDescription":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"4 years and 25 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"11" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"10" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)", "OutcomeMeasureDescription":"Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.", "OutcomeMeasurePopulationDescription":"One participant was not evaluable and came off study due to infection prior to restaging. Two participants were not evaluable due to withdrawal from the study or lack of measurable disease. Three patients with stable disease at 3 months elected to pursue alternate treatment and did not have 5 month restaging.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"3 and 5 months restaging", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"16" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"11" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Stable disease at 3 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Stable disease at 5 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Partial response at 3 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Partial response at 5 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Progressive disease at 3 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Progressive disease at 5 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)", "OutcomeMeasureDescription":"Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "OutcomeMeasurePopulationDescription":"Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"percentage of PBMC", "OutcomeMeasureTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Median CD4 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"37.70", "OutcomeMeasurementLowerLimit":"24.11", "OutcomeMeasurementUpperLimit":"46.36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"43.57", "OutcomeMeasurementLowerLimit":"40.26", "OutcomeMeasurementUpperLimit":"46.87" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"29.30", "OutcomeMeasurementLowerLimit":"24.65", "OutcomeMeasurementUpperLimit":"39.77" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"33.58", "OutcomeMeasurementLowerLimit":"26.84", "OutcomeMeasurementUpperLimit":"39.92" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.61", "OutcomeMeasurementLowerLimit":"24.44", "OutcomeMeasurementUpperLimit":"47.73" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"33.44", "OutcomeMeasurementLowerLimit":"33.37", "OutcomeMeasurementUpperLimit":"33.52" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"34.29", "OutcomeMeasurementLowerLimit":"25.56", "OutcomeMeasurementUpperLimit":"37.44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"27.99", "OutcomeMeasurementLowerLimit":"25.85", "OutcomeMeasurementUpperLimit":"39.38" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.87", "OutcomeMeasurementLowerLimit":"8.26", "OutcomeMeasurementUpperLimit":"16.86" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.77", "OutcomeMeasurementLowerLimit":"3.49", "OutcomeMeasurementUpperLimit":"26.04" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"15.96", "OutcomeMeasurementLowerLimit":"10.76", "OutcomeMeasurementUpperLimit":"19.48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"13.76", "OutcomeMeasurementLowerLimit":"10.31", "OutcomeMeasurementUpperLimit":"19.77" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.67", "OutcomeMeasurementLowerLimit":"9.102", "OutcomeMeasurementUpperLimit":"16.57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13.63", "OutcomeMeasurementLowerLimit":"4.123", "OutcomeMeasurementUpperLimit":"23.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"15.42", "OutcomeMeasurementLowerLimit":"10.96", "OutcomeMeasurementUpperLimit":"22.44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16.02", "OutcomeMeasurementLowerLimit":"10.57", "OutcomeMeasurementUpperLimit":"25.5" } ] } } ] } },{ "OutcomeClassTitle":"Median B cells Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.05", "OutcomeMeasurementLowerLimit":"6.19", "OutcomeMeasurementUpperLimit":"10.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11.02", "OutcomeMeasurementLowerLimit":"9.92", "OutcomeMeasurementUpperLimit":"12.11" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.97", "OutcomeMeasurementLowerLimit":"3.54", "OutcomeMeasurementUpperLimit":"12.13" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7.82", "OutcomeMeasurementLowerLimit":"3.13", "OutcomeMeasurementUpperLimit":"12.07" } ] } } ] } },{ "OutcomeClassTitle":"Median B cells d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.93", "OutcomeMeasurementLowerLimit":"6.16", "OutcomeMeasurementUpperLimit":"10.58" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.78", "OutcomeMeasurementLowerLimit":"7.95", "OutcomeMeasurementUpperLimit":"11.62" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.10", "OutcomeMeasurementLowerLimit":"5.07", "OutcomeMeasurementUpperLimit":"12.17" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8.77", "OutcomeMeasurementLowerLimit":"3.78", "OutcomeMeasurementUpperLimit":"10.72" } ] } } ] } },{ "OutcomeClassTitle":"Median Natural Killer (NK) Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.21", "OutcomeMeasurementLowerLimit":"4.14", "OutcomeMeasurementUpperLimit":"6.94" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.57", "OutcomeMeasurementLowerLimit":"3.27", "OutcomeMeasurementUpperLimit":"9.87" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5.72", "OutcomeMeasurementLowerLimit":"3.13", "OutcomeMeasurementUpperLimit":"8.51" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.89", "OutcomeMeasurementLowerLimit":"4.59", "OutcomeMeasurementUpperLimit":"9.14" } ] } } ] } },{ "OutcomeClassTitle":"Median Natural Killer (NK) d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.72", "OutcomeMeasurementLowerLimit":"4.03", "OutcomeMeasurementUpperLimit":"7.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.41", "OutcomeMeasurementLowerLimit":"5.50", "OutcomeMeasurementUpperLimit":"11.31" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4.22", "OutcomeMeasurementLowerLimit":"3.97", "OutcomeMeasurementUpperLimit":"10.07" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9.14", "OutcomeMeasurementLowerLimit":"5.95", "OutcomeMeasurementUpperLimit":"11.4" } ] } } ] } },{ "OutcomeClassTitle":"Median Natural Killer T cell (NKT) Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.65", "OutcomeMeasurementUpperLimit":"4.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.70", "OutcomeMeasurementLowerLimit":"0.46", "OutcomeMeasurementUpperLimit":"2.94" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.27", "OutcomeMeasurementLowerLimit":"0.62", "OutcomeMeasurementUpperLimit":"2.81" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.24", "OutcomeMeasurementLowerLimit":"0.59", "OutcomeMeasurementUpperLimit":"4.39" } ] } } ] } },{ "OutcomeClassTitle":"Median Natural Killer T cell (NKT) d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.25", "OutcomeMeasurementLowerLimit":"0.67", "OutcomeMeasurementUpperLimit":"4.75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.46", "OutcomeMeasurementLowerLimit":"0.51", "OutcomeMeasurementUpperLimit":"4.40" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.19", "OutcomeMeasurementLowerLimit":"0.58", "OutcomeMeasurementUpperLimit":"3.15" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.53", "OutcomeMeasurementLowerLimit":"0.77", "OutcomeMeasurementUpperLimit":"5.86" } ] } } ] } },{ "OutcomeClassTitle":"Median cDC Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.25", "OutcomeMeasurementLowerLimit":"0.14", "OutcomeMeasurementUpperLimit":"0.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.14", "OutcomeMeasurementLowerLimit":"0.11", "OutcomeMeasurementUpperLimit":"0.17" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementLowerLimit":"0.20", "OutcomeMeasurementUpperLimit":"0.37" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementLowerLimit":"0.16", "OutcomeMeasurementUpperLimit":"0.35" } ] } } ] } },{ "OutcomeClassTitle":"Median cDC d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.18", "OutcomeMeasurementLowerLimit":"0.14", "OutcomeMeasurementUpperLimit":"0.23" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementLowerLimit":"0.16", "OutcomeMeasurementUpperLimit":"0.19" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.21", "OutcomeMeasurementLowerLimit":"0.18", "OutcomeMeasurementUpperLimit":"0.34" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.19", "OutcomeMeasurementLowerLimit":"0.09", "OutcomeMeasurementUpperLimit":"0.23" } ] } } ] } },{ "OutcomeClassTitle":"Median pDC Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.25", "OutcomeMeasurementLowerLimit":"0.20", "OutcomeMeasurementUpperLimit":"0.37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.17", "OutcomeMeasurementLowerLimit":"0.09", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementLowerLimit":"0.17", "OutcomeMeasurementUpperLimit":"0.36" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementLowerLimit":"0.11", "OutcomeMeasurementUpperLimit":"0.31" } ] } } ] } },{ "OutcomeClassTitle":"Median pDC d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.32", "OutcomeMeasurementLowerLimit":"0.27", "OutcomeMeasurementUpperLimit":"0.38" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.26", "OutcomeMeasurementLowerLimit":"0.08", "OutcomeMeasurementUpperLimit":"0.44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.27", "OutcomeMeasurementLowerLimit":"0.18", "OutcomeMeasurementUpperLimit":"0.35" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementLowerLimit":"0.14", "OutcomeMeasurementUpperLimit":"0.40" } ] } } ] } },{ "OutcomeClassTitle":"Median MDSC Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.98", "OutcomeMeasurementLowerLimit":"2.96", "OutcomeMeasurementUpperLimit":"19.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.53", "OutcomeMeasurementLowerLimit":"4.30", "OutcomeMeasurementUpperLimit":"12.76" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8.47", "OutcomeMeasurementLowerLimit":"5.98", "OutcomeMeasurementUpperLimit":"14.54" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"13.73", "OutcomeMeasurementLowerLimit":"5.41", "OutcomeMeasurementUpperLimit":"17.61" } ] } } ] } },{ "OutcomeClassTitle":"Median MDSC d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.41", "OutcomeMeasurementLowerLimit":"4.82", "OutcomeMeasurementUpperLimit":"18.78" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.78", "OutcomeMeasurementLowerLimit":"5.98", "OutcomeMeasurementUpperLimit":"15.58" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7.55", "OutcomeMeasurementLowerLimit":"4.95", "OutcomeMeasurementUpperLimit":"12.16" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"12.77", "OutcomeMeasurementLowerLimit":"6.64", "OutcomeMeasurementUpperLimit":"14.23" } ] } } ] } },{ "OutcomeClassTitle":"Median Treg Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.77", "OutcomeMeasurementLowerLimit":"0.66", "OutcomeMeasurementUpperLimit":"0.90" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.90", "OutcomeMeasurementLowerLimit":"0.68", "OutcomeMeasurementUpperLimit":"1.13" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.25", "OutcomeMeasurementLowerLimit":"0.73", "OutcomeMeasurementUpperLimit":"1.74" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.07", "OutcomeMeasurementLowerLimit":"0.55", "OutcomeMeasurementUpperLimit":"1.60" } ] } } ] } },{ "OutcomeClassTitle":"Median Treg d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.81", "OutcomeMeasurementLowerLimit":"0.78", "OutcomeMeasurementUpperLimit":"1.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.80", "OutcomeMeasurementLowerLimit":"0.42", "OutcomeMeasurementUpperLimit":"1.17" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.12", "OutcomeMeasurementLowerLimit":"0.83", "OutcomeMeasurementUpperLimit":"1.71" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.45", "OutcomeMeasurementUpperLimit":"1.41" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 EM Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.58", "OutcomeMeasurementLowerLimit":"8.47", "OutcomeMeasurementUpperLimit":"12.73" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.09", "OutcomeMeasurementLowerLimit":"9.67", "OutcomeMeasurementUpperLimit":"14.51" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"13.14", "OutcomeMeasurementLowerLimit":"10.67", "OutcomeMeasurementUpperLimit":"14.82" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"11.31", "OutcomeMeasurementLowerLimit":"8.49", "OutcomeMeasurementUpperLimit":"15.97" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 EM d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.92", "OutcomeMeasurementLowerLimit":"7.49", "OutcomeMeasurementUpperLimit":"13.48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.72", "OutcomeMeasurementLowerLimit":"9.20", "OutcomeMeasurementUpperLimit":"12.25" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"12.50", "OutcomeMeasurementLowerLimit":"11.33", "OutcomeMeasurementUpperLimit":"13.63" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9.76", "OutcomeMeasurementLowerLimit":"7.21", "OutcomeMeasurementUpperLimit":"15.68" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 CM Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.29", "OutcomeMeasurementLowerLimit":"8.59", "OutcomeMeasurementUpperLimit":"21.10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.20", "OutcomeMeasurementLowerLimit":"12.62", "OutcomeMeasurementUpperLimit":"33.79" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"12.36", "OutcomeMeasurementLowerLimit":"9.16", "OutcomeMeasurementUpperLimit":"17.44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"12.07", "OutcomeMeasurementLowerLimit":"7.52", "OutcomeMeasurementUpperLimit":"16.56" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 CM d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18.80", "OutcomeMeasurementLowerLimit":"9.75", "OutcomeMeasurementUpperLimit":"24.37" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16.51", "OutcomeMeasurementLowerLimit":"10.97", "OutcomeMeasurementUpperLimit":"22.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"12.78", "OutcomeMeasurementLowerLimit":"10.53", "OutcomeMeasurementUpperLimit":"17.98" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"11.36", "OutcomeMeasurementLowerLimit":"6.00", "OutcomeMeasurementUpperLimit":"14.40" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 EMRA Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.32", "OutcomeMeasurementLowerLimit":"0.28", "OutcomeMeasurementUpperLimit":"1.96" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.68", "OutcomeMeasurementLowerLimit":"0.21", "OutcomeMeasurementUpperLimit":"1.15" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.34", "OutcomeMeasurementLowerLimit":"0.26", "OutcomeMeasurementUpperLimit":"0.90" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.28", "OutcomeMeasurementLowerLimit":"0.21", "OutcomeMeasurementUpperLimit":"1.04" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 EMRA d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.34", "OutcomeMeasurementLowerLimit":"0.26", "OutcomeMeasurementUpperLimit":"0.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.83", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"1.43" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.28", "OutcomeMeasurementLowerLimit":"0.23", "OutcomeMeasurementUpperLimit":"0.56" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.38", "OutcomeMeasurementLowerLimit":"0.21", "OutcomeMeasurementUpperLimit":"1.75" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 naive Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.28", "OutcomeMeasurementLowerLimit":"4.23", "OutcomeMeasurementUpperLimit":"12.36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.57", "OutcomeMeasurementLowerLimit":"3.23", "OutcomeMeasurementUpperLimit":"11.91" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.78", "OutcomeMeasurementLowerLimit":"2.47", "OutcomeMeasurementUpperLimit":"6.90" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4.49", "OutcomeMeasurementLowerLimit":"2.56", "OutcomeMeasurementUpperLimit":"10.22" } ] } } ] } },{ "OutcomeClassTitle":"Median CD4 naive d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.48", "OutcomeMeasurementLowerLimit":"4.14", "OutcomeMeasurementUpperLimit":"12.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.41", "OutcomeMeasurementLowerLimit":"2.08", "OutcomeMeasurementUpperLimit":"8.73" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.99", "OutcomeMeasurementLowerLimit":"3.49", "OutcomeMeasurementUpperLimit":"7.51" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6.08", "OutcomeMeasurementLowerLimit":"3.15", "OutcomeMeasurementUpperLimit":"9.55" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 EM Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.20", "OutcomeMeasurementLowerLimit":"2.33", "OutcomeMeasurementUpperLimit":"6.85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.70", "OutcomeMeasurementLowerLimit":"1.54", "OutcomeMeasurementUpperLimit":"3.86" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7.19", "OutcomeMeasurementLowerLimit":"4.45", "OutcomeMeasurementUpperLimit":"8.92" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.23", "OutcomeMeasurementLowerLimit":"4.21", "OutcomeMeasurementUpperLimit":"7.64" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 EM d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.44", "OutcomeMeasurementLowerLimit":"2.85", "OutcomeMeasurementUpperLimit":"6.87" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.33", "OutcomeMeasurementLowerLimit":"2.61", "OutcomeMeasurementUpperLimit":"4.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6.60", "OutcomeMeasurementLowerLimit":"4.12", "OutcomeMeasurementUpperLimit":"10.78" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6.11", "OutcomeMeasurementLowerLimit":"3.91", "OutcomeMeasurementUpperLimit":"7.30" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 CM Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.03", "OutcomeMeasurementLowerLimit":"0.61", "OutcomeMeasurementUpperLimit":"2.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.05", "OutcomeMeasurementLowerLimit":"0.80", "OutcomeMeasurementUpperLimit":"1.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.16", "OutcomeMeasurementLowerLimit":"0.56", "OutcomeMeasurementUpperLimit":"1.48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1.00", "OutcomeMeasurementLowerLimit":"0.53", "OutcomeMeasurementUpperLimit":"1.38" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 CM d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.31", "OutcomeMeasurementLowerLimit":"0.81", "OutcomeMeasurementUpperLimit":"2.43" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.86", "OutcomeMeasurementLowerLimit":"0.53", "OutcomeMeasurementUpperLimit":"1.19" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.95", "OutcomeMeasurementLowerLimit":"0.80", "OutcomeMeasurementUpperLimit":"1.44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.88", "OutcomeMeasurementLowerLimit":"0.32", "OutcomeMeasurementUpperLimit":"1.26" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 EMRA Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.01", "OutcomeMeasurementLowerLimit":"1.22", "OutcomeMeasurementUpperLimit":"8.46" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.51", "OutcomeMeasurementLowerLimit":"0.63", "OutcomeMeasurementUpperLimit":"4.39" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.60", "OutcomeMeasurementLowerLimit":"1.36", "OutcomeMeasurementUpperLimit":"9.95" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.81", "OutcomeMeasurementLowerLimit":"2.26", "OutcomeMeasurementUpperLimit":"8.75" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 EMRA d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.84", "OutcomeMeasurementLowerLimit":"1.40", "OutcomeMeasurementUpperLimit":"7.35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.24", "OutcomeMeasurementLowerLimit":"0.69", "OutcomeMeasurementUpperLimit":"5.80" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.31", "OutcomeMeasurementLowerLimit":"1.14", "OutcomeMeasurementUpperLimit":"10.71" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5.06", "OutcomeMeasurementLowerLimit":"3.11", "OutcomeMeasurementUpperLimit":"10.83" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 naive Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.47", "OutcomeMeasurementLowerLimit":"2.50", "OutcomeMeasurementUpperLimit":"5.60" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.51", "OutcomeMeasurementLowerLimit":"0.53", "OutcomeMeasurementUpperLimit":"16.49" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.43", "OutcomeMeasurementLowerLimit":"0.92", "OutcomeMeasurementUpperLimit":"5.25" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.71", "OutcomeMeasurementLowerLimit":"2.86", "OutcomeMeasurementUpperLimit":"5.92" } ] } } ] } },{ "OutcomeClassTitle":"Median CD8 naive d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.28", "OutcomeMeasurementLowerLimit":"2.58", "OutcomeMeasurementUpperLimit":"6.21" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.20", "OutcomeMeasurementLowerLimit":"0.30", "OutcomeMeasurementUpperLimit":"12.09" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3.12", "OutcomeMeasurementLowerLimit":"1.00", "OutcomeMeasurementUpperLimit":"5.82" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.44", "OutcomeMeasurementLowerLimit":"2.06", "OutcomeMeasurementUpperLimit":"5.45" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.5221", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.25", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.50", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.16", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.8665", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.88", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.84", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.57", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.3052", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of B cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test", "OutcomeAnalysisStatisticalComment":"The reported p-value is representative of the changes in levels of B cells at dose level 1." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of B cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.65", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of B cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0698", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NK cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.74", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NK cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NK cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0127", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NKT cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.41", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NKT cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.07", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of NKT cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0654", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.38", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of cDC cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.21", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of cDC cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.16", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of cDC cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0457", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of pDC cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.55", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of pDC cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of pDC cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.7114", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.38", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.91", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.2666", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.88", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of Treg cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.45", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of Treg cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.36", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of Treg cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0076", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.38", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.22", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.10", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.7144", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.06", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.3741", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.13", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.3386", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.88", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0215", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.65", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.5076", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.68", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.73", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.6577", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.88", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.74", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.20", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.6295", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.36", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.8314", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.64", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.30", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in Serum Levels of Cytokines", "OutcomeMeasureDescription":"Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "OutcomeMeasurePopulationDescription":"Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"pg/ml", "OutcomeMeasureTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Median IFNg Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.63", "OutcomeMeasurementLowerLimit":"2.47", "OutcomeMeasurementUpperLimit":"6.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.56", "OutcomeMeasurementLowerLimit":"2.99", "OutcomeMeasurementUpperLimit":"4.13" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.805", "OutcomeMeasurementLowerLimit":"1.97", "OutcomeMeasurementUpperLimit":"3.6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4.47", "OutcomeMeasurementLowerLimit":"4.05", "OutcomeMeasurementUpperLimit":"7.48" } ] } } ] } },{ "OutcomeClassTitle":"Median IFNg d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.64", "OutcomeMeasurementLowerLimit":"2.17", "OutcomeMeasurementUpperLimit":"3.17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.83", "OutcomeMeasurementLowerLimit":"2.62", "OutcomeMeasurementUpperLimit":"3.04" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.84", "OutcomeMeasurementLowerLimit":"1.76", "OutcomeMeasurementUpperLimit":"4.71" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4.9", "OutcomeMeasurementLowerLimit":"2.91", "OutcomeMeasurementUpperLimit":"6.81" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-10 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.17", "OutcomeMeasurementUpperLimit":"0.54" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.215", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.23" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.21", "OutcomeMeasurementLowerLimit":"0.17", "OutcomeMeasurementUpperLimit":"0.28" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.31", "OutcomeMeasurementUpperLimit":"0.47" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-10 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.26", "OutcomeMeasurementLowerLimit":"0.23", "OutcomeMeasurementUpperLimit":"0.39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.285", "OutcomeMeasurementLowerLimit":"0.28", "OutcomeMeasurementUpperLimit":"0.29" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.18", "OutcomeMeasurementUpperLimit":"0.31" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.4", "OutcomeMeasurementLowerLimit":"0.26", "OutcomeMeasurementUpperLimit":"0.52" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-12p70 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.22", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.37" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-12p70 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementLowerLimit":"0.2", "OutcomeMeasurementUpperLimit":"0.26" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-1b Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"1.15" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"2.52" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-1b d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.24" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.24", "OutcomeMeasurementLowerLimit":"0.24", "OutcomeMeasurementUpperLimit":"0.89" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-2 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"2.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.64" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.64" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.80" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-2 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.93" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.64" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.64" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.64", "OutcomeMeasurementLowerLimit":"0.64", "OutcomeMeasurementUpperLimit":"0.70" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-6 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.88", "OutcomeMeasurementLowerLimit":"0.71", "OutcomeMeasurementUpperLimit":"2.85" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.78", "OutcomeMeasurementLowerLimit":"0.66", "OutcomeMeasurementUpperLimit":"0.9" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.02", "OutcomeMeasurementLowerLimit":"0.52", "OutcomeMeasurementUpperLimit":"1.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.37", "OutcomeMeasurementLowerLimit":"0.69", "OutcomeMeasurementUpperLimit":"15.3" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-6 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.97", "OutcomeMeasurementLowerLimit":"0.74", "OutcomeMeasurementUpperLimit":"1.23" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.855", "OutcomeMeasurementLowerLimit":"0.76", "OutcomeMeasurementUpperLimit":"0.95" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.04", "OutcomeMeasurementLowerLimit":"0.54", "OutcomeMeasurementUpperLimit":"1.97" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.84", "OutcomeMeasurementLowerLimit":"0.90", "OutcomeMeasurementUpperLimit":"4.84" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-8 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56.45", "OutcomeMeasurementLowerLimit":"16.84", "OutcomeMeasurementUpperLimit":"487.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"43.87", "OutcomeMeasurementLowerLimit":"16.05", "OutcomeMeasurementUpperLimit":"71.69" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"37.49", "OutcomeMeasurementLowerLimit":"18", "OutcomeMeasurementUpperLimit":"91.01" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"63.52", "OutcomeMeasurementLowerLimit":"33.7", "OutcomeMeasurementUpperLimit":"560.2" } ] } } ] } },{ "OutcomeClassTitle":"Median IL-8 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33.29", "OutcomeMeasurementLowerLimit":"30.52", "OutcomeMeasurementUpperLimit":"124.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.85", "OutcomeMeasurementLowerLimit":"44.98", "OutcomeMeasurementUpperLimit":"78.71" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"43.27", "OutcomeMeasurementLowerLimit":"17.99", "OutcomeMeasurementUpperLimit":"140.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"73.21", "OutcomeMeasurementLowerLimit":"38.62", "OutcomeMeasurementUpperLimit":"200.9" } ] } } ] } },{ "OutcomeClassTitle":"Median TNF Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.54", "OutcomeMeasurementLowerLimit":"1.19", "OutcomeMeasurementUpperLimit":"8.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.315", "OutcomeMeasurementLowerLimit":"1.24", "OutcomeMeasurementUpperLimit":"1.39" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.62", "OutcomeMeasurementLowerLimit":"1.25", "OutcomeMeasurementUpperLimit":"2.26" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3.59", "OutcomeMeasurementLowerLimit":"2.19", "OutcomeMeasurementUpperLimit":"9.24" } ] } } ] } },{ "OutcomeClassTitle":"Median TNF d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.63", "OutcomeMeasurementLowerLimit":"1.45", "OutcomeMeasurementUpperLimit":"1.81" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.465", "OutcomeMeasurementLowerLimit":"1.23", "OutcomeMeasurementUpperLimit":"1.7" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1.67", "OutcomeMeasurementLowerLimit":"1.38", "OutcomeMeasurementUpperLimit":"2.07" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.74", "OutcomeMeasurementLowerLimit":"2.26", "OutcomeMeasurementUpperLimit":"3.77" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.375", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.4808", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.7334", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.7109", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.4347", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.748", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.8203", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test", "OutcomeAnalysisStatisticalComment":"The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.5625", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.5", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.6846", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.5", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.4375", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.75", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.4525", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test", "OutcomeAnalysisStatisticalComment":"The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.875", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisGroupDescription":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.", "OutcomeAnalysisPValue":"0.4316", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.9906", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.625", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test", "OutcomeAnalysisStatisticalComment":"The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1." },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.791", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.8203", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":">0.9999", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.875", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.9658", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.6523", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in Soluble Cluster of Differentiation 27 (sCD27)", "OutcomeMeasureDescription":"Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "OutcomeMeasurePopulationDescription":"Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"U/ml", "OutcomeMeasureTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Median sCD27 Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"99.07", "OutcomeMeasurementLowerLimit":"91.13", "OutcomeMeasurementUpperLimit":"131" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"98.63", "OutcomeMeasurementLowerLimit":"87.12", "OutcomeMeasurementUpperLimit":"110.1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"97.47", "OutcomeMeasurementLowerLimit":"85.15", "OutcomeMeasurementUpperLimit":"110.9" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"128.4", "OutcomeMeasurementLowerLimit":"123.9", "OutcomeMeasurementUpperLimit":"145.6" } ] } } ] } },{ "OutcomeClassTitle":"Median sCD27 d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"97.17", "OutcomeMeasurementLowerLimit":"92.07", "OutcomeMeasurementUpperLimit":"1112" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.07", "OutcomeMeasurementLowerLimit":"83.3", "OutcomeMeasurementUpperLimit":"100.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"101.7", "OutcomeMeasurementLowerLimit":"98.85", "OutcomeMeasurementUpperLimit":"105.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"133.1", "OutcomeMeasurementLowerLimit":"129.7", "OutcomeMeasurementUpperLimit":"155.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.2901", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.375", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.2036", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0742", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)", "OutcomeMeasureDescription":"Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "OutcomeMeasurePopulationDescription":"Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"Ratio", "OutcomeMeasureTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Median sCD27:sCD40L Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.982", "OutcomeMeasurementLowerLimit":"5.71", "OutcomeMeasurementUpperLimit":"11.67" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.57", "OutcomeMeasurementLowerLimit":"7.88", "OutcomeMeasurementUpperLimit":"11.26" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.571", "OutcomeMeasurementLowerLimit":"7.67", "OutcomeMeasurementUpperLimit":"19.89" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8.57", "OutcomeMeasurementLowerLimit":"6.93", "OutcomeMeasurementUpperLimit":"10.62" } ] } } ] } },{ "OutcomeClassTitle":"Median sCD27:sCD40L d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.428", "OutcomeMeasurementLowerLimit":"4.79", "OutcomeMeasurementUpperLimit":"9.43" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.294", "OutcomeMeasurementLowerLimit":"7.29", "OutcomeMeasurementUpperLimit":"9.29" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"10.47", "OutcomeMeasurementLowerLimit":"6.63", "OutcomeMeasurementUpperLimit":"19.38" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8.257", "OutcomeMeasurementLowerLimit":"6.96", "OutcomeMeasurementUpperLimit":"8.91" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.1004", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.625", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.6772", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.3008", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Changes in Soluble Cluster of Differentiation 40L (sCD40L)", "OutcomeMeasureDescription":"Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.", "OutcomeMeasurePopulationDescription":"Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ng/ml", "OutcomeMeasureTimeFrame":"Pre (Baseline) and Day 85 after 6 vaccinations", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"4 YU (Dose Level 1)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"16 YU (Dose Level 2)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"40 YU (Dose Level 3)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"80 YU (Dose Level 4)", "OutcomeGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Median sCD40L Pre", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.3", "OutcomeMeasurementLowerLimit":"11.39", "OutcomeMeasurementUpperLimit":"17.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.24", "OutcomeMeasurementLowerLimit":"9.78", "OutcomeMeasurementUpperLimit":"11.06" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.648", "OutcomeMeasurementLowerLimit":"5.27", "OutcomeMeasurementUpperLimit":"13.99" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14.72", "OutcomeMeasurementLowerLimit":"13.67", "OutcomeMeasurementUpperLimit":"18.74" } ] } } ] } },{ "OutcomeClassTitle":"Median sCD40L d85", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.23", "OutcomeMeasurementLowerLimit":"11.96", "OutcomeMeasurementUpperLimit":"19.42" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11.14", "OutcomeMeasurementLowerLimit":"10.84", "OutcomeMeasurementUpperLimit":"11.43" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.854", "OutcomeMeasurementLowerLimit":"5.86", "OutcomeMeasurementUpperLimit":"14.52" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"18.57", "OutcomeMeasurementLowerLimit":"16.09", "OutcomeMeasurementUpperLimit":"19.51" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.0621", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.875", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.2402", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.", "OutcomeAnalysisPValue":"0.3008", "OutcomeAnalysisPValueComment":"The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.", "OutcomeAnalysisStatisticalMethod":"Wilcoxon test" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"4 years and 25 days", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"4 YU (Dose Level 1)", "EventGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"4", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"4", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"4" },{ "EventGroupId":"EG001", "EventGroupTitle":"16 YU (Dose Level 2)", "EventGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"3", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"3", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"3" },{ "EventGroupId":"EG002", "EventGroupTitle":"40 YU (Dose Level 3)", "EventGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"16", "EventGroupSeriousNumAffected":"5", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"16", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG003", "EventGroupTitle":"80 YU (Dose Level 4)", "EventGroupDescription":"Yeast-Brachyury vaccine will be administered subcutaneously at 4 sites on 7 visits, then monthly until patients meet off-treatment criteria.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"11", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"11", "EventGroupOtherNumAffected":"10", "EventGroupOtherNumAtRisk":"11" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"11" } ] } },{ "SeriousEventTerm":"Aortic valve disease", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"11" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"11" } ] } },{ "SeriousEventTerm":"Chest wall pain", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"11" } ] } },{ "SeriousEventTerm":"Hyperglycemia", "SeriousEventOrganSystem":"Metabolism and nutrition disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"4" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"3" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"11" } ] } },{ "SeriousEventTerm":"Small intestinal obstruction", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"CTCAE (4.0)", 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