Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00384033
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2006-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).', 'otherNumAtRisk': 161, 'otherNumAffected': 129, 'seriousNumAtRisk': 161, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).', 'otherNumAtRisk': 148, 'otherNumAffected': 134, 'seriousNumAtRisk': 148, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).', 'otherNumAtRisk': 150, 'otherNumAffected': 134, 'seriousNumAtRisk': 150, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).', 'otherNumAtRisk': 157, 'otherNumAffected': 141, 'seriousNumAtRisk': 157, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Flu syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Abnormal vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'seriousEvents': [{'term': 'Accidental injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.68', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-9.75', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-10.3', 'spread': '0.60', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '2.70', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.', 'groupDescription': 'For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '0.20', 'ciUpperLimit': '3.40', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.', 'groupDescription': 'For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '0.00', 'ciUpperLimit': '3.40', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': '1 = Very much improved', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': '2 = Much improved', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': '3 = Minimally improved', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': '4 = No change', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}, {'title': '5 = Minimally worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8 or FOT', 'description': 'CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.44', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '-1.41', 'spread': '0.10', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.40', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.60', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.60', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': "CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '31.10', 'spread': 'NA', 'comment': 'Standard error (SE) for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '30.10', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '30.70', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '30.80', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 or FOT', 'categories': [{'measurements': [{'value': '-11.00', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-12.70', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '-14.40', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '-14.40', 'spread': '0.87', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '4.00', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '1.10', 'ciUpperLimit': '5.60', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.40', 'ciLowerLimit': '1.10', 'ciUpperLimit': '5.80', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'MADRS measures the overall severity of depressive 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).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.49', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '3.53', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '3.70', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '3.50', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 or FOT', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '-1.26', 'spread': '0.12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.46', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.119', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.61', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.710', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.40', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.00', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '12.80', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '12.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '12.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 or FOT', 'categories': [{'measurements': [{'value': '-4.82', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-5.41', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-6.15', 'spread': '0.34', 'groupId': 'OG002'}, {'value': '-5.91', 'spread': '0.36', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '1.50', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.40', 'ciUpperLimit': '2.30', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.10', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.38', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '8.43', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '8.51', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '8.38', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 or FOT', 'categories': [{'measurements': [{'value': '-3.13', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-3.66', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '-3.92', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-3.80', 'spread': '0.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.17', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.16', 'ciUpperLimit': '1.42', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.06', 'ciUpperLimit': '1.38', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.50', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '6.30', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '6.30', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '6.30', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 or FOT', 'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '-1.47', 'spread': '0.13', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.50', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.70', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.90', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'OG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'classes': [{'title': 'Overall pain (Baseline)', 'categories': [{'measurements': [{'value': '26.30', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '30.80', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '25.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '26.10', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Stomach pain (Baseline)', 'categories': [{'measurements': [{'value': '16.70', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '19.40', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '17.00', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '14.00', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Back pain (Baseline)', 'categories': [{'measurements': [{'value': '25.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '32.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '28.30', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '25.50', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Chest pain (Baseline)', 'categories': [{'measurements': [{'value': '9.40', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '10.90', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '10.40', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '6.60', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Arms, legs or joint pain (Baseline)', 'categories': [{'measurements': [{'value': '25.80', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG000'}, {'value': '29.10', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG001'}, {'value': '28.70', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG002'}, {'value': '22.40', 'spread': 'NA', 'comment': 'SE for baseline was not obtained for secondary variables as the focus was on adjusting for baseline, not on baseline comparison.', 'groupId': 'OG003'}]}]}, {'title': 'Overall pain (Change at Week 8 or FOT)', 'categories': [{'measurements': [{'value': '-5.61', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '-9.08', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-10.30', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '-8.84', 'spread': '1.74', 'groupId': 'OG003'}]}]}, {'title': 'Stomach pain (Change at Week 8 or FOT)', 'categories': [{'measurements': [{'value': '-1.86', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '-4.98', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '-6.42', 'spread': '1.68', 'groupId': 'OG002'}, {'value': '-4.38', 'spread': '1.58', 'groupId': 'OG003'}]}]}, {'title': 'Back pain (Change at Week 8 or FOT)', 'categories': [{'measurements': [{'value': '-7.04', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-10.70', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '-12.80', 'spread': '1.73', 'groupId': 'OG002'}, {'value': '-9.33', 'spread': '1.83', 'groupId': 'OG003'}]}]}, {'title': 'Chest pain (Change at Week 8 or FOT)', 'categories': [{'measurements': [{'value': '-1.95', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '-3.90', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '-1.67', 'spread': '1.21', 'groupId': 'OG003'}]}]}, {'title': 'Arms, legs or joint pain (Change at Week 8 or FOT)', 'categories': [{'measurements': [{'value': '-6.99', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-8.98', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-11.90', 'spread': '1.76', 'groupId': 'OG002'}, {'value': '-8.35', 'spread': '1.64', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.50', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '7.90', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '0.30', 'ciUpperLimit': '9.10', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.10', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '8.80', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.10', 'ciLowerLimit': '-1.40', 'ciUpperLimit': '7.70', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.048', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.60', 'ciLowerLimit': '0.10', 'ciUpperLimit': '9.10', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.088', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.80', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '8.10', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.122', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.70', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '8.40', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.80', 'ciLowerLimit': '1.10', 'ciUpperLimit': '10.50', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.103', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.20', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '9.20', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '4.50', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.221', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '5.10', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.411', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '4.70', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '6.70', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.90', 'ciLowerLimit': '0.20', 'ciUpperLimit': '9.60', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.155', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '7.80', 'pValueComment': 'The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.', 'groupDescription': 'For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who had a baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study medication, and had at least 1 primary efficacy evaluation after the first dose of double-blind study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'FG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'FG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'FG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '159'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study was conducted from 27 September 2006 to 28 September 2007 in United States (US) only.', 'preAssignmentDetails': 'A total of 925 participants were screened for this study and 638 participants were randomized. The remaining 287 participants were not randomized due to screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}, {'value': '616', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'BG001', 'title': 'DVS SR 50 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'BG002', 'title': 'DVS SR 100 mg', 'description': 'DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).'}, {'id': 'BG003', 'title': 'Duloxetine 60 mg', 'description': 'Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.24', 'spread': '12.74', 'groupId': 'BG000'}, {'value': '40.67', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '38.77', 'spread': '12.07', 'groupId': 'BG002'}, {'value': '38.94', 'spread': '12.01', 'groupId': 'BG003'}, {'value': '39.39', 'spread': '12.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '399', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '217', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hamilton psychiatric scale for depression-17 item (HAM-D17) total score', 'classes': [{'categories': [{'measurements': [{'value': '23.86', 'spread': '2.68', 'groupId': 'BG000'}, {'value': '23.49', 'spread': '2.52', 'groupId': 'BG001'}, {'value': '23.49', 'spread': '2.55', 'groupId': 'BG002'}, {'value': '22.99', 'spread': '2.45', 'groupId': 'BG003'}, {'value': '23.46', 'spread': '2.57', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50. N=160 for placebo treatment group.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical global impressions scale-severity (CGI-S) score', 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '4.29', 'spread': '0.48', 'groupId': 'BG001'}, {'value': '4.31', 'spread': '0.49', 'groupId': 'BG002'}, {'value': '4.28', 'spread': '0.46', 'groupId': 'BG003'}, {'value': '4.32', 'spread': '0.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. N=160 for placebo treatment group.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-09', 'studyFirstSubmitDate': '2006-10-02', 'resultsFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2006-10-02', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-09', 'studyFirstPostDateStruct': {'date': '2006-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0 = none/absent and 4 = most severe, for a maximum total score of 50.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Categorical Scores on CGI-Improvement (CGI-I) Score at Week 8 or FOT Evaluation', 'timeFrame': 'Week 8 or FOT', 'description': 'CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale relative to the baseline assessment. Higher score = more affected.'}, {'measure': 'Change From Baseline in Mean CGI-S Score at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': "CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected."}, {'measure': 'Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'MADRS measures the overall severity of depressive 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).'}, {'measure': 'Change From Baseline in the Lassitude Item of the MADRS Scale at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'Lassitude item of MADRS represents a difficulty in getting started or slowness in initiating and performing everyday activities. It is rated on a scale of 0-6: 0 = hardly any difficulty in getting started/no sluggishness; 2 = difficulties in starting activities; 4 = difficulties in starting simple routine activities which are carried out with effort; 6 = complete lassitude/unable to do anything without help.'}, {'measure': 'Change From Baseline in HAM-D6 Total Score at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 (0=none and 2=severe) and all others are scored 0-4 (0=none/absent and 4=most severe).'}, {'measure': 'Change From Baseline in the HAM-D Energy Subscale Score at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'HAM-D energy subscale is a subset of the HAM-D17 that assesses 4 items associated with major depression. The scale uses HAM- D17 items 1, 7, 8 and 14. Item 14 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe).'}, {'measure': 'Change From Baseline in Covi Anxiety Scale at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'COVI anxiety scale measures the severity of anxiety symptoms on 3 items: verbal report, behavior and somatic complaints. Each dimension is assessed using a 5-point scale: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = considerably, to 5 = Very much. Worst value is 15 and best value is 3.'}, {'measure': 'Change From Baseline in Visual Analog Scale-Pain Intensity (VAS-PI) Overall and Subcomponent Score at Week 8 or FOT Evaluation', 'timeFrame': 'Baseline and Week 8 or FOT', 'description': 'VAS-PI scale assesses intensity of back pain, chest pain, arms, legs or joint pain as well as overall pain intensity where 100 mm line (VAS) is marked by participant and intensity of pain ranges from 0 millimetre (mm) = no pain to 100 mm = worst possible pain. There were separate 0 to 100 mm VAS lines for each subcomponent of VAS-PI.'}]}, 'conditionsModule': {'keywords': ['MDD', 'Major Depressive Disorder', 'Depression'], 'conditions': ['Depressive Disorder, Major']}, 'referencesModule': {'references': [{'pmid': '34183490', 'type': 'DERIVED', 'citation': 'Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.'}, {'pmid': '29140227', 'type': 'DERIVED', 'citation': 'Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.'}, {'pmid': '26709542', 'type': 'DERIVED', 'citation': 'McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.'}, {'pmid': '26644956', 'type': 'DERIVED', 'citation': 'McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015.'}, {'pmid': '25758058', 'type': 'DERIVED', 'citation': 'Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.'}, {'pmid': '24571916', 'type': 'DERIVED', 'citation': 'Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.'}, {'pmid': '19698901', 'type': 'DERIVED', 'citation': 'Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther. 2009 Jun;31 Pt 1:1405-23. doi: 10.1016/j.clinthera.2009.07.006.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-335&StudyName=Study%20Evaluating%20Desvenlafaxine%20Succinate%20Sustained%20Release%20%28DVS%20SR%29%20In%20The%20Treatment%20Of%20Major%20Depressive%20Disorder%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.\n* Depressive symptoms for at least 30 days before the screening visit.\n* Outpatient men and women at least 18 years of age.\n\nExclusion Criteria:\n\n* Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.\n* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.\n* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.'}, 'identificationModule': {'nctId': 'NCT00384033', 'briefTitle': 'Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder', 'orgStudyIdInfo': {'id': '3151A1-335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desvenlafaxine succinate sustained-release 50 mg', 'interventionNames': ['Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)']}, {'type': 'EXPERIMENTAL', 'label': 'Desvenlafaxine succinate sustained-release 100 mg', 'interventionNames': ['Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 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