{"protocolSection":{"identificationModule":{"nctId":"NCT01687478","orgStudyIdInfo":{"id":"13702"},"secondaryIdInfos":[{"id":"F1D-CR-HGNB","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression","officialTitle":"A Study to Assess the Short-Term Efficacy and Safety of Olanzapine and Fluoxetine Compared to Placebo and Fluoxetine for Nonpsychotic Treatment-Resistant Depression"},"statusModule":{"statusVerifiedDate":"2019-09","overallStatus":"TERMINATED","whyStopped":"Interim assessment: Lack of efficacy","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-09"},"primaryCompletionDateStruct":{"date":"2015-11","type":"ACTUAL"},"completionDateStruct":{"date":"2015-11","type":"ACTUAL"},"studyFirstSubmitDate":"2012-09-07","studyFirstSubmitQcDate":"2012-09-13","studyFirstPostDateStruct":{"date":"2012-09-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-11-16","resultsFirstSubmitQcDate":"2017-08-23","resultsFirstPostDateStruct":{"date":"2017-08-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-09-25","lastUpdatePostDateStruct":{"date":"2019-10-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine compared to placebo and fluoxetine as treatment for treatment-resistant depression (TRD) in Chinese participants."},"conditionsModule":{"conditions":["Treatment Resistant Depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":176,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Olanzapine + Fluoxetine","type":"EXPERIMENTAL","description":"Olanzapine starting dose is 5 milligram (mg) (1 tablet). May titrate up to 10 mg (2 tablets), or 15 mg (3 tablets) administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.","interventionNames":["Drug: Olanzapine","Drug: Fluoxetine"]},{"label":"Placebo + Fluoxetine","type":"PLACEBO_COMPARATOR","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.","interventionNames":["Drug: Fluoxetine","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Olanzapine","description":"Administered Orally","armGroupLabels":["Olanzapine + Fluoxetine"],"otherNames":["LY170053","Zyprexa"]},{"type":"DRUG","name":"Fluoxetine","description":"Administered Orally","armGroupLabels":["Olanzapine + Fluoxetine","Placebo + Fluoxetine"],"otherNames":["LY110140","Prozac"]},{"type":"DRUG","name":"Placebo","description":"Administered Orally","armGroupLabels":["Placebo + Fluoxetine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)","description":"The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)\\*Visit.","timeFrame":"Baseline, 8 Weeks"}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale","description":"CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)\\*Visit.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)","description":"SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)","description":"SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)","description":"SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score","description":"The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.","timeFrame":"Baseline,8 Weeks"},{"measure":"Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks","description":"The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)","description":"BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.","timeFrame":"Baseline, 8 Weeks"},{"measure":"Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)","description":"AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.","timeFrame":"Baseline, 8 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have single or recurrent unipolar major depressive disorder (MDD) without psychotic features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) clinical assessment\n* Have a total score ≥22 on the 17-item Hamilton Depression Rating Scale (HAM-D17) at screening and randomization\n* Have treatment-resistant depression (TRD), defined as having failed to achieve a satisfactory antidepressant response, in the opinion of the investigator, to separate treatment courses of at least 2 different antidepressants, other than fluoxetine, of adequate dosage and duration (≥6 weeks) within the current major depressive episode\n\nExclusion Criteria:\n\n* Have a diagnosis of Parkinson's disease or a related disorder\n* Have a current or lifetime diagnosis of any of the following conditions, according to DSM-IV-TR criteria: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Delusional Disorder; Psychotic Disorder Not Otherwise Specified; Bipolar Disorder I or II; Delirium of any type; Dementia of any type; Amnestic Disorder; any Substance-Induced Disorder; or any Psychotic Disorder due to a General Medical Condition\n* Have a current diagnosis of post-partum depression or MDD with a seasonal pattern as defined in the DSM-IV-TR\n* Have paranoid, schizoid, schizotypal, antisocial, or borderline personality disorder (Axis II) as a comorbid or primary diagnosis, based on DSM-IV-TR criteria\n* Have DSM-IV-TR substance dependence/abuse or are not willing to avoid use of the substance (not including dependence on nicotine or caffeine) within 30 days of screening\n* Are actively suicidal in the judgment of the investigator\n* Have uncorrected narrow-angle glaucoma\n* Have had one or more seizures without a clear and resolved etiology\n* Have leukopenia\n* Have any acute, serious, or unstable medical conditions\n* Have an increased serum prolactin concentration at screening\n* Have a rate-corrected cardiac QT interval, calculated using Bazett's formula (QTc Bazett's \\[Rate-corrected cardiac QT interval on electrocardiogram calculated using Bazett's formula(QTcB)\\]), on Electrocardiogram (ECG) \\>450 milliseconds (male) or \\>470 milliseconds (female) at screening\n* Have a history of allergic reaction to olanzapine, fluoxetine, or olanzapine in combination with fluoxetine\n* Have had treatment with olanzapine, fluoxetine, or olanzapine in combination with fluoxetine withdrawn due to clinically significant and/or intolerable adverse effects within 6 months of screening\n* Have received treatment with remoxipride within 6 months of randomization\n* Have received treatment with depot antipsychotics within one dosing interval before randomization\n* Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current MDD episode, or has a history of failure to respond to adequate treatment courses of ECT or VNS, or is expected to require ECT or VNS at any time during the study\n* Have received previous treatment with clozapine\n* Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of screening, or are expected to need MAOI treatment at any time during the study or up until 5 weeks after study discontinuation","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Baoding","zip":"071000","country":"China","geoPoint":{"lat":38.87288,"lon":115.46246}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Beijing","zip":"100088","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Changsha","zip":"410011","country":"China","geoPoint":{"lat":28.19874,"lon":112.97087}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Guangzhou","zip":"510080","country":"China","geoPoint":{"lat":23.11667,"lon":113.25}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hangzhou","zip":"310009","country":"China","geoPoint":{"lat":30.29365,"lon":120.16142}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kunming","zip":"650032","country":"China","geoPoint":{"lat":25.03889,"lon":102.71833}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Nanjing","zip":"210029","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Shanghai","zip":"200030","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Wuhan","zip":"430022","country":"China","geoPoint":{"lat":30.58333,"lon":114.26667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Xi'an","zip":"710061","country":"China","geoPoint":{"lat":34.25833,"lon":108.92861}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Xinxiang","zip":"453002","country":"China","geoPoint":{"lat":35.19033,"lon":113.80151}}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"FG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"88"},{"groupId":"FG001","numSubjects":"88"}]},{"type":"Safety Analysis Set","achievements":[{"groupId":"FG000","numSubjects":"88"},{"groupId":"FG001","numSubjects":"87"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"56"},{"groupId":"FG001","numSubjects":"49"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"39"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"19"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Entry Criteria Not Met","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants.","groups":[{"id":"BG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"BG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"176"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"38.63","spread":"12.18"},{"groupId":"BG001","value":"41.45","spread":"12.44"},{"groupId":"BG002","value":"40.04","spread":"12.36"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"99"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"176"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"176"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"176"}]}]}]},{"title":"Montgomery-Äsberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.1","spread":"5.3"},{"groupId":"BG001","value":"31.8","spread":"4.8"},{"groupId":"BG002","value":"32.0","spread":"5.0"}]}]}]},{"title":"17 Item Hamilton Rating Scale for Depression (HAM-D17) Total Score","description":"The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24.6","spread":"2.6"},{"groupId":"BG001","value":"25.0","spread":"2.6"},{"groupId":"BG002","value":"24.8","spread":"2.6"}]}]}]},{"title":"Clinical Global Impressions-Severity of Depression (CGI-S)","description":"The CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.9","spread":"0.6"},{"groupId":"BG001","value":"4.9","spread":"0.7"},{"groupId":"BG002","value":"4.9","spread":"0.7"}]}]}]},{"title":"Age of First Major Depressive Disorder (MDD) Episode","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.92","spread":"12.61"},{"groupId":"BG001","value":"34.07","spread":"12.69"},{"groupId":"BG002","value":"30.00","spread":"12.79"}]}]}]},{"title":"Years Since the First MDD Episode","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.71","spread":"6.21"},{"groupId":"BG001","value":"7.38","spread":"7.86"},{"groupId":"BG002","value":"8.05","spread":"7.10"}]}]}]},{"title":"Years Since the Most Recent MDD Episode","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.66","spread":"5.12"},{"groupId":"BG001","value":"3.23","spread":"4.15"},{"groupId":"BG002","value":"3.45","spread":"4.65"}]}]}]},{"title":"Number of Previous Lifetime MDD Episodes","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Number of MDD Episodes","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.4","spread":"1.4"},{"groupId":"BG001","value":"1.3","spread":"2.1"},{"groupId":"BG002","value":"1.3","spread":"1.8"}]}]}]},{"title":"Number of Previous MDD Episodes Within the Last 36 Months","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Number of MDD Episodes","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.5","spread":"0.8"},{"groupId":"BG001","value":"0.5","spread":"1.1"},{"groupId":"BG002","value":"0.5","spread":"0.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)","description":"The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)\\*Visit.","populationDescription":"Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.92","spread":"1.20"},{"groupId":"OG001","value":"-14.30","spread":"1.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Mean Difference (Net)","paramValue":"-1.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.04","ciUpperLimit":"1.80","estimateComment":"The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine."}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale","description":"CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)\\*Visit.","populationDescription":"Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.43","spread":"0.15"},{"groupId":"OG001","value":"-1.63","spread":"0.16"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)","description":"SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"87"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"1.71"},{"groupId":"OG001","value":"-0.14","spread":"1.72"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)","description":"SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.","populationDescription":"All randomized participants.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"88"}]}],"classes":[{"title":"Physical Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"2.20","spread":"7.51"},{"groupId":"OG001","value":"0.70","spread":"7.47"}]}]},{"title":"Role-Physical","categories":[{"measurements":[{"groupId":"OG000","value":"3.99","spread":"11.79"},{"groupId":"OG001","value":"3.93","spread":"11.23"}]}]},{"title":"Bodily Pain","categories":[{"measurements":[{"groupId":"OG000","value":"6.81","spread":"12.05"},{"groupId":"OG001","value":"0.02","spread":"11.30"}]}]},{"title":"General Health","categories":[{"measurements":[{"groupId":"OG000","value":"5.82","spread":"11.49"},{"groupId":"OG001","value":"2.84","spread":"9.44"}]}]},{"title":"Vitality","categories":[{"measurements":[{"groupId":"OG000","value":"7.43","spread":"13.54"},{"groupId":"OG001","value":"5.04","spread":"9.83"}]}]},{"title":"Social Functioning","categories":[{"measurements":[{"groupId":"OG000","value":"6.13","spread":"13.55"},{"groupId":"OG001","value":"4.56","spread":"11.78"}]}]},{"title":"Role-Emotional","categories":[{"measurements":[{"groupId":"OG000","value":"6.61","spread":"12.39"},{"groupId":"OG001","value":"6.71","spread":"12.12"}]}]},{"title":"Mental Health","categories":[{"measurements":[{"groupId":"OG000","value":"8.98","spread":"13.46"},{"groupId":"OG001","value":"8.43","spread":"11.99"}]}]},{"title":"Mental Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"8.87","spread":"14.29"},{"groupId":"OG001","value":"8.73","spread":"12.54"}]}]},{"title":"Physical Component Score","categories":[{"measurements":[{"groupId":"OG000","value":"2.87","spread":"7.59"},{"groupId":"OG001","value":"-0.65","spread":"7.22"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)","description":"SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.","populationDescription":"All randomized participants.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"88"}]}],"classes":[{"title":"Work/School (n=68,65)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.34","spread":"2.71"},{"groupId":"OG001","value":"-1.55","spread":"2.89"}]}]},{"title":"Social Life (n=79,79)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.70","spread":"2.66"},{"groupId":"OG001","value":"-1.49","spread":"2.85"}]}]},{"title":"Family Life (n=79,78)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.63","spread":"3.00"},{"groupId":"OG001","value":"-1.53","spread":"2.66"}]}]},{"title":"SDS Total Score (68,64)","categories":[{"measurements":[{"groupId":"OG000","value":"-4.57","spread":"7.75"},{"groupId":"OG001","value":"-4.41","spread":"7.89"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score","description":"The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.","populationDescription":"All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Baseline,8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"65.5"},{"groupId":"OG001","value":"61.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks","description":"The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.","populationDescription":"All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent of participants","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.9"},{"groupId":"OG001","value":"38.8"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)","description":"BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"87"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.01","spread":"2.24"},{"groupId":"OG001","value":"-0.04","spread":"2.13"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)","description":"AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 8 Weeks","groups":[{"id":"OG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."},{"id":"OG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"87"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","spread":"1.47"},{"groupId":"OG001","value":"-0.31","spread":"3.28"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"All participants in the safety analysis set.","eventGroups":[{"id":"EG000","title":"Olanzapine + Fluoxetine","description":"Olanzapine starting dose is 5 milligram (mg). May titrate up to 10 mg, or 15 mg administered once daily by mouth for 8 weeks.\n\nFluoxetine starting dose is 20 mg. May titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.","seriousNumAffected":1,"seriousNumAtRisk":88,"otherNumAffected":55,"otherNumAtRisk":88},{"id":"EG001","title":"Placebo + Fluoxetine","description":"Placebo matches the Olanzapine tablet for blinding.\n\nFluoxetine starting dose is 20 mg, then may titrate up to 40 mg or 50 mg administered once daily by mouth for 8 weeks.","seriousNumAffected":1,"seriousNumAtRisk":87,"otherNumAffected":45,"otherNumAtRisk":87}],"seriousEvents":[{"term":"Restlessness","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Suicide attempt","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 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18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":87}]},{"term":"Dry mouth","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Haematochezia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":87}]},{"term":"Retching","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Salivary hypersecretion","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Tongue disorder","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Asthenia","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":88},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":87}]},{"term":"Chest discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":87}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Discomfort","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":87}]},{"term":"Fatigue","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Gait disturbance","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Hunger","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Oedema","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Sensation of foreign body","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Thirst","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Hepatic function abnormal","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Liver disorder","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Liver injury","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":87}]},{"term":"Hypersensitivity","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Nasopharyngitis","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Upper respiratory tract infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Skin injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":88},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":87}]},{"term":"Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA 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