{"protocolSection":{"identificationModule":{"nctId":"NCT00727064","orgStudyIdInfo":{"id":"3151A1-4414"},"organization":{"fullName":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects","officialTitle":"A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers"},"statusModule":{"statusVerifiedDate":"2010-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-06"},"primaryCompletionDateStruct":{"date":"2008-08","type":"ACTUAL"},"completionDateStruct":{"date":"2008-08","type":"ACTUAL"},"studyFirstSubmitDate":"2008-07-29","studyFirstSubmitQcDate":"2008-07-31","studyFirstPostDateStruct":{"date":"2008-08-01","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-08-31","resultsFirstSubmitQcDate":"2010-03-30","resultsFirstPostDateStruct":{"date":"2010-04-19","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-05-26","lastUpdatePostDateStruct":{"date":"2010-06-02","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Wyeth (Registry Contact: Clinical Trial Registry Specialist)","oldOrganization":"Wyeth"},"leadSponsor":{"name":"Wyeth is now a wholly owned subsidiary of Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK) between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered."},"conditionsModule":{"conditions":["Healthy"],"keywords":["Healthy Subjects"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":14,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"DVS/VEN","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)","Drug: Venlafaxine Extended Release (VEN ER)"]},{"label":"VEN/DVS","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)","Drug: Venlafaxine Extended Release (VEN ER)"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","armGroupLabels":["DVS/VEN","VEN/DVS"]},{"type":"DRUG","name":"Venlafaxine Extended Release (VEN ER)","armGroupLabels":["DVS/VEN","VEN/DVS"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status","description":"Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","timeFrame":"single dose"},{"measure":"Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","timeFrame":"single dose"},{"measure":"Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","timeFrame":"single dose"},{"measure":"Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","timeFrame":"single dose"},{"measure":"Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status","description":"Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","timeFrame":"single dose"},{"measure":"Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","timeFrame":"single dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy men and women aged 18 to 55 years. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).\n* History of being a nonsmoker for at least 1 year.\n* Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1 or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active enzyme gene alleles) via genetic testing of a blood sample.\n\nExclusion Criteria:\n\n* Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease or any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure).\n* Known or suspected alcohol abuse or consumption of more than 2 standard units per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine) within the past 6 months.\n* Known or suspected current abuse of prohibited drugs or other substances. Use of any hormonal therapy within 30 days before study day -1 until the end of the partial inpatient confinement period.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Medical Monitor","affiliation":"Wyeth is now a wholly owned subsidiary of Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Clinical Research Institute","city":"Wichita","state":"Kansas","zip":"67211","country":"United States","geoPoint":{"lat":37.69224,"lon":-97.33754}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were screened for cytochrome P450 2D6 (CYP2D6) genotype to identify 7 \"extensive metabolizers\" and 7 \"poor metabolizers\" (inclusion criteria). Eligible participants were then randomly assigned to a sequence group.","recruitmentDetails":"Participants were recruited in the United States from June 2008 to August 2008.","groups":[{"id":"FG000","title":"Sequence Group A","description":"Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling."},{"id":"FG001","title":"Sequence Group B","description":"Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sequence Group A","description":"Day 1: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 75mg oral dose of Venlafaxine ER (VEN ER) in a fasting state. Day 11-16: 120 hours of PK sampling."},{"id":"BG001","title":"Sequence Group B","description":"Day 1: single 75mg oral dose of Venlafaxine Extended Release (VEN ER) in a fasting state. Days 1-6: 120 hours of PK sampling. Days 7-10: Wash out period. Day 11: single 50mg oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) in a fasting state. Day 11-16: 120 hours of PK sampling."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"30.14","spread":"10.37"},{"groupId":"BG001","value":"28.29","spread":"8.90"},{"groupId":"BG002","value":"29.21","spread":"9.33"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"4"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status","description":"Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.16","spread":"17.70","lowerLimit":"20.01","upperLimit":"34.19"},{"groupId":"OG001","value":"77.46","spread":"32.36","lowerLimit":"59.25","upperLimit":"101.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng*h/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"389.68","spread":"462.45","lowerLimit":"247.02","upperLimit":"614.72"},{"groupId":"OG001","value":"2328.41","spread":"3460.47","lowerLimit":"1475.99","upperLimit":"3673.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]},{"type":"PRIMARY","title":"Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95.63","spread":"27.40","lowerLimit":"51.77","upperLimit":"176.68"},{"groupId":"OG001","value":"15.73","spread":"20.27","lowerLimit":"8.51","upperLimit":"29.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng*h/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2703.50","spread":"540.96","lowerLimit":"1191.90","upperLimit":"6132.19"},{"groupId":"OG001","value":"436.14","spread":"442.86","lowerLimit":"192.28","upperLimit":"989.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.018","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]},{"type":"PRIMARY","title":"Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status","description":"Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"102.22","spread":"15.35","lowerLimit":"83.52","upperLimit":"125.12"},{"groupId":"OG001","value":"125.32","spread":"28.34","lowerLimit":"101.80","upperLimit":"154.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.081","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status","description":"AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.","populationDescription":"All participants from sequence groups A and B who received a single dose of venlafaxine ER.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-08","paramType":"GEOMETRIC_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"ng*h/mL (90% CI)","timeFrame":"single dose","groups":[{"id":"OG000","title":"Extensive Metabolizers (EM)","description":"Identified as EM from CYP2D6 testing at screening"},{"id":"OG001","title":"Poor Metabolizers (PM)","description":"Identified as PM from CYP2D6 testing at screening"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2701.79","spread":"414.79","lowerLimit":"2024.74","upperLimit":"3605.25"},{"groupId":"OG001","value":"3111.25","spread":"1050.76","lowerLimit":"2316.01","upperLimit":"4179.55"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.427","statisticalMethod":"ANOVA","statisticalComment":"PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors."}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Desvenlafaxine Succinate Sustained-Release (DVS SR)","description":"SAE or AE reported on DVS SR regardless of which arm or period of trial.","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":2},{"id":"EG001","title":"Venlafaxine Extended Release (VEN ER)","description":"SAE or AE reported on VEN ER regardless of which arm or period of trial.","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":4}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":7}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":2,"numAtRisk":7}]},{"term":"Syncope vasovagal","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":7}]},{"term":"Insomina","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":7}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication."},"pointOfContact":{"title":"U. S. Contact Center","organization":"Wyeth","email":"clintrialresults@wyeth.com"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"}},"hasResults":true}