Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-26 @ 5:07 PM
Study NCT ID:
NCT01443403
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2011-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620491', 'term': 'naldemedine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).', 'description': 'The safety population included all participants who received study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.', 'otherNumAtRisk': 61, 'otherNumAffected': 19, 'seriousNumAtRisk': 61, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.', 'otherNumAtRisk': 61, 'otherNumAffected': 15, 'seriousNumAtRisk': 61, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.', 'otherNumAtRisk': 60, 'otherNumAffected': 19, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.', 'otherNumAtRisk': 61, 'otherNumAffected': 28, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '0.422', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.422', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '0.429', 'groupId': 'OG002'}, {'value': '3.64', 'spread': '0.437', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '1.02', 'ciUpperLimit': '3.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.605', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '0.76', 'ciUpperLimit': '3.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.604', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.3504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '1.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.599', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug.', 'unitOfMeasure': 'spontaneous bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.507', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.507', 'groupId': 'OG001'}, {'value': '4.05', 'spread': '0.516', 'groupId': 'OG002'}, {'value': '4.52', 'spread': '0.525', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.402', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.402', 'groupId': 'OG001'}, {'value': '2.99', 'spread': '0.410', 'groupId': 'OG002'}, {'value': '3.87', 'spread': '0.416', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.374', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.372', 'groupId': 'OG001'}, {'value': '3.07', 'spread': '0.380', 'groupId': 'OG002'}, {'value': '3.33', 'spread': '0.384', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.409', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.409', 'groupId': 'OG001'}, {'value': '3.30', 'spread': '0.415', 'groupId': 'OG002'}, {'value': '3.41', 'spread': '0.420', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to randomization.', 'unitOfMeasure': 'spontaneous bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '0.396', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.394', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '0.404', 'groupId': 'OG002'}, {'value': '3.36', 'spread': '0.408', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '0.81', 'ciUpperLimit': '3.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.568', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.79', 'ciUpperLimit': '3.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.569', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.2572', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '1.73', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.558', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA BM was defined as all bowel movements observed irrespective of the use of a laxative agent.', 'unitOfMeasure': 'bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.456', 'groupId': 'OG001'}, {'value': '4.25', 'spread': '0.466', 'groupId': 'OG002'}, {'value': '4.60', 'spread': '0.472', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.361', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.360', 'groupId': 'OG001'}, {'value': '2.96', 'spread': '0.369', 'groupId': 'OG002'}, {'value': '3.75', 'spread': '0.373', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.347', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.344', 'groupId': 'OG001'}, {'value': '3.02', 'spread': '0.352', 'groupId': 'OG002'}, {'value': '2.93', 'spread': '0.354', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.52', 'spread': '0.373', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.372', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '0.379', 'groupId': 'OG002'}, {'value': '3.16', 'spread': '0.381', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA BM was defined as all bowel movements observed irrespective of the use of a laxative agent.', 'unitOfMeasure': 'bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.08', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.336', 'groupId': 'OG001'}, {'value': '2.71', 'spread': '0.344', 'groupId': 'OG002'}, {'value': '2.41', 'spread': '0.348', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0065', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.38', 'ciUpperLimit': '2.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.484', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.482', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.2921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '1.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.476', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': "Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'", 'unitOfMeasure': 'complete bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.381', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.380', 'groupId': 'OG001'}, {'value': '2.88', 'spread': '0.388', 'groupId': 'OG002'}, {'value': '3.14', 'spread': '0.394', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.324', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.324', 'groupId': 'OG001'}, {'value': '1.99', 'spread': '0.331', 'groupId': 'OG002'}, {'value': '2.50', 'spread': '0.336', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.297', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.296', 'groupId': 'OG001'}, {'value': '2.29', 'spread': '0.302', 'groupId': 'OG002'}, {'value': '2.12', 'spread': '0.305', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.333', 'groupId': 'OG001'}, {'value': '2.77', 'spread': '0.339', 'groupId': 'OG002'}, {'value': '2.56', 'spread': '0.342', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': "Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'", 'unitOfMeasure': 'complete bowel movements per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '0.345', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.344', 'groupId': 'OG001'}, {'value': '2.69', 'spread': '0.351', 'groupId': 'OG002'}, {'value': '2.44', 'spread': '0.356', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.47', 'ciUpperLimit': '2.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.495', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '0.73', 'ciUpperLimit': '2.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.492', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.3077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '1.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.488', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.', 'unitOfMeasure': 'complete spontaneous BMs per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.386', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.386', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '0.393', 'groupId': 'OG002'}, {'value': '2.99', 'spread': '0.399', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '1.09', 'spread': '0.326', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.326', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '0.332', 'groupId': 'OG002'}, {'value': '2.50', 'spread': '0.337', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.303', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.301', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.307', 'groupId': 'OG002'}, {'value': '2.21', 'spread': '0.311', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.340', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.340', 'groupId': 'OG001'}, {'value': '2.77', 'spread': '0.345', 'groupId': 'OG002'}, {'value': '2.58', 'spread': '0.349', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.', 'unitOfMeasure': 'complete spontaneous BMs per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}, {'value': '71.2', 'groupId': 'OG002'}, {'value': '66.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.3', 'ciLowerLimit': '10.0', 'ciUpperLimit': '44.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.8', 'ciLowerLimit': '15.0', 'ciUpperLimit': '48.7', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1461', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '30.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM responder was defined as a participant whose frequency of SBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of SBMs from baseline of 1 or more per week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week1', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '62.3', 'groupId': 'OG001'}, {'value': '72.9', 'groupId': 'OG002'}, {'value': '70.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '55.7', 'groupId': 'OG001'}, {'value': '69.5', 'groupId': 'OG002'}, {'value': '70.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '55.7', 'groupId': 'OG001'}, {'value': '74.6', 'groupId': 'OG002'}, {'value': '73.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}, {'value': '64.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM responder was defined as any participant whose frequency of SBM per week during the treatment period was 3 times or more per week, and who had an average increase from baseline of 1 or more per week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population; missing data were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}, {'value': '45.8', 'groupId': 'OG002'}, {'value': '45.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0050', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.3', 'ciLowerLimit': '7.8', 'ciUpperLimit': '40.8', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0045', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.5', 'ciLowerLimit': '8.1', 'ciUpperLimit': '40.8', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2984', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '23.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM responder was defined as a participant whose frequency of CSBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}, {'value': '42.4', 'groupId': 'OG002'}, {'value': '50.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}, {'value': '42.4', 'groupId': 'OG002'}, {'value': '40.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '37.7', 'groupId': 'OG001'}, {'value': '44.1', 'groupId': 'OG002'}, {'value': '45.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}, {'value': '45.8', 'groupId': 'OG002'}, {'value': '43.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM responder was defined as a participant whose frequency of CSBMs during the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population; missing data were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.223', 'groupId': 'OG001'}, {'value': '2.10', 'spread': '0.227', 'groupId': 'OG002'}, {'value': '2.42', 'spread': '0.232', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.320', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.320', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0698', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '1.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.317', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement.', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.251', 'groupId': 'OG001'}, {'value': '2.35', 'spread': '0.255', 'groupId': 'OG002'}, {'value': '2.38', 'spread': '0.260', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '2.03', 'spread': '0.245', 'groupId': 'OG002'}, {'value': '2.45', 'spread': '0.250', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.233', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '0.232', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '0.237', 'groupId': 'OG002'}, {'value': '2.37', 'spread': '0.240', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.274', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '0.274', 'groupId': 'OG001'}, {'value': '2.20', 'spread': '0.278', 'groupId': 'OG002'}, {'value': '2.52', 'spread': '0.281', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement.', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.213', 'groupId': 'OG001'}, {'value': '1.93', 'spread': '0.217', 'groupId': 'OG002'}, {'value': '2.02', 'spread': '0.221', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.307', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.305', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.1648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '1.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.302', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.234', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.234', 'groupId': 'OG001'}, {'value': '1.74', 'spread': '0.238', 'groupId': 'OG002'}, {'value': '2.14', 'spread': '0.242', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.226', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '0.226', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.230', 'groupId': 'OG002'}, {'value': '1.93', 'spread': '0.234', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.223', 'groupId': 'OG001'}, {'value': '1.71', 'spread': '0.228', 'groupId': 'OG002'}, {'value': '1.98', 'spread': '0.230', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.256', 'groupId': 'OG001'}, {'value': '2.17', 'spread': '0.260', 'groupId': 'OG002'}, {'value': '2.10', 'spread': '0.262', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.', 'unitOfMeasure': 'days/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Time to the First Spontaneous Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.57', 'groupId': 'OG000', 'lowerLimit': '34.70', 'upperLimit': '71.25'}, {'value': '28.15', 'groupId': 'OG001', 'lowerLimit': '15.75', 'upperLimit': '45.02'}, {'value': '11.08', 'groupId': 'OG002', 'lowerLimit': '4.15', 'upperLimit': '25.25'}, {'value': '21.33', 'groupId': 'OG003', 'lowerLimit': '4.67', 'upperLimit': '26.92'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Time to the first SBM was defined as the time to the first SBM after the initial administration of study drug. Participants who withdrew from the study before an SBM was observed or had no SBM during the treatment period were treated as censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Time to the First Complete Spontaneous Bowel Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '223.92', 'groupId': 'OG000', 'lowerLimit': '101.25', 'upperLimit': '350.40'}, {'value': '82.50', 'groupId': 'OG001', 'lowerLimit': '49.30', 'upperLimit': '140.40'}, {'value': '44.83', 'groupId': 'OG002', 'lowerLimit': '25.58', 'upperLimit': '107.17'}, {'value': '32.93', 'groupId': 'OG003', 'lowerLimit': '18.00', 'upperLimit': '55.08'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0079', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Time to the first CSBM was defined as the time to the first CSBM after the initial administration of study drug. Participants who withdrew from the study before a CSBM was observed or had no CSBM during the treatment period were treated as censored.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Up to 4 hours', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '18.0', 'groupId': 'OG001'}, {'value': '35.6', 'groupId': 'OG002'}, {'value': '31.6', 'groupId': 'OG003'}]}]}, {'title': 'Up to 8 hours', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}, {'value': '42.1', 'groupId': 'OG003'}]}]}, {'title': 'Up to 12 hours', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}, {'value': '50.8', 'groupId': 'OG002'}, {'value': '43.9', 'groupId': 'OG003'}]}]}, {'title': 'Up to 24 hours', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '44.3', 'groupId': 'OG001'}, {'value': '59.3', 'groupId': 'OG002'}, {'value': '59.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4, 8, 12, and 24 hours', 'description': 'The percentage of participants who experienced at least one SBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Up to 4 hours', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}, {'value': '18.6', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'Up to 8 hours', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}, {'value': '20.3', 'groupId': 'OG002'}, {'value': '24.6', 'groupId': 'OG003'}]}]}, {'title': 'Up to 12 hours', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '21.3', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'Up to 24 hours', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}, {'value': '43.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4, 8, 12, and 24 hours', 'description': 'The percentage of participants who experienced at least one CSBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.249', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.249', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '0.256', 'groupId': 'OG002'}, {'value': '1.87', 'spread': '0.259', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.62', 'ciUpperLimit': '2.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.358', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.359', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.1211', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '1.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.352', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.', 'unitOfMeasure': 'spontaneous bowel movements/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.278', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.278', 'groupId': 'OG001'}, {'value': '2.16', 'spread': '0.285', 'groupId': 'OG002'}, {'value': '1.76', 'spread': '0.288', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.270', 'groupId': 'OG001'}, {'value': '2.03', 'spread': '0.278', 'groupId': 'OG002'}, {'value': '1.98', 'spread': '0.281', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.261', 'groupId': 'OG001'}, {'value': '2.03', 'spread': '0.268', 'groupId': 'OG002'}, {'value': '1.91', 'spread': '0.270', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.307', 'groupId': 'OG001'}, {'value': '2.01', 'spread': '0.313', 'groupId': 'OG002'}, {'value': '1.94', 'spread': '0.315', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.', 'unitOfMeasure': 'spontaneous bowel movements/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.383', 'groupId': 'OG001'}, {'value': '2.92', 'spread': '0.391', 'groupId': 'OG002'}, {'value': '3.21', 'spread': '0.396', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.28', 'ciUpperLimit': '3.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.551', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.07', 'ciLowerLimit': '0.99', 'ciUpperLimit': '3.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.549', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}, {'pValue': '0.2022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '1.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.542', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model with treatment group as a term and baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score of 0 or 1.', 'unitOfMeasure': 'bowel movements/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.442', 'groupId': 'OG001'}, {'value': '3.23', 'spread': '0.451', 'groupId': 'OG002'}, {'value': '3.46', 'spread': '0.457', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 60, 59, 56)', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.382', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.382', 'groupId': 'OG001'}, {'value': '2.54', 'spread': '0.390', 'groupId': 'OG002'}, {'value': '3.27', 'spread': '0.394', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.371', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.369', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '0.377', 'groupId': 'OG002'}, {'value': '3.06', 'spread': '0.381', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 60, 60, 59, 57)', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.358', 'groupId': 'OG001'}, {'value': '2.82', 'spread': '0.365', 'groupId': 'OG002'}, {'value': '2.84', 'spread': '0.368', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining is defined as a BM with a straining score of 0 or 1.', 'unitOfMeasure': 'bowel movements/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.71', 'spread': '5.105', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '4.568', 'groupId': 'OG001'}, {'value': '-3.75', 'spread': '5.673', 'groupId': 'OG002'}, {'value': '-2.80', 'spread': '5.353', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted).', 'unitOfMeasure': 'false start BMs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with values at both baseline and the last 2 weeks of the treatment period'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '6.068', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '1.691', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '07.211', 'groupId': 'OG002'}, {'value': '-1.24', 'spread': '2.847', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0272', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1355', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3689', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).', 'unitOfMeasure': 'doses/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Mean Rescue Laxative Use Per Week During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '7.64', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '4.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1 to 4', 'description': 'Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).', 'unitOfMeasure': 'doses/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.689', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.759', 'groupId': 'OG001'}, {'value': '-0.54', 'spread': '0.719', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.773', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2126', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2799', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6466', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with a value at both baseline and the last 2 weeks of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.592', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.621', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.760', 'groupId': 'OG002'}, {'value': '-0.48', 'spread': '0.692', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 61, 59, 56)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.654', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.812', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.839', 'groupId': 'OG002'}, {'value': '-0.68', 'spread': '0.745', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.666', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.874', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.933', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.818', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.769', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.903', 'groupId': 'OG002'}, {'value': '-0.63', 'spread': '0.784', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with a value at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.703', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '0.991', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9826', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5188', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5029', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': "Welch's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with a value at both baseline and the last 2 weeks of treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Week 1 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.652', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.609', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.755', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.652', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 (n = 61, 61, 59, 56)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.705', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.752', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.825', 'groupId': 'OG002'}, {'value': '-0.49', 'spread': '0.713', 'groupId': 'OG003'}]}]}, {'title': 'Week 3 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.741', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.859', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '0.884', 'groupId': 'OG002'}, {'value': '-0.45', 'spread': '1.001', 'groupId': 'OG003'}]}]}, {'title': 'Week 4 (n = 61, 61, 59, 57)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.684', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.787', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.703', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '0.991', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population with a value at both baseline and the specified time point.'}, {'type': 'SECONDARY', 'title': 'Subject Global Satisfaction at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Markedly worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Moderately worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Slightly worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Slightly improved', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Moderately improved', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Markedly improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29, or at early termination', 'description': 'On day 29 (or at early termination), participants were asked about their degree of satisfaction with constipation and abdominal symptoms from the start of study drug dosing to Day 28 (or early termination visit). The grades were as follows: 1, markedly worsened; 2, moderately worsened; 3, slightly worsened; 4, unchanged; 5, slightly improved; 6, moderately improved; and 7, markedly improved.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Naldemedine Day 1 (n = 9, 9, 10)', 'categories': [{'measurements': [{'value': '0.987', 'spread': '41.1', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '48.2', 'groupId': 'OG001'}, {'value': '3.67', 'spread': '41.3', 'groupId': 'OG002'}]}]}, {'title': 'Naldemedine Day 28 (n = 4, 4, 4)', 'categories': [{'measurements': [{'value': '1.15', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '4.03', 'spread': '32.3', 'groupId': 'OG002'}]}]}, {'title': 'Nor-S-297995 Day 1 (n = 9, 9, 10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable as plasma concentrations of Nor-S-297995 on Day 1 were below the limit of quantification.', 'groupId': 'OG000'}, {'value': '0.107', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '0.184', 'spread': '30.9', 'groupId': 'OG002'}]}]}, {'title': 'Nor-S-297995 Day 28 (n = 4, 4, 4)', 'categories': [{'measurements': [{'value': '0.111', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '0.148', 'spread': '59.9', 'groupId': 'OG001'}, {'value': '0.218', 'spread': '58.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter population (PK population) includes all participants who received study drug with at least one PK parameter estimated adequately on Day 1 or Day 28'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Naldemedine Day 1 (n = 9, 9, 10)', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '2.27'}, {'value': '1.03', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '4.02'}, {'value': '1.03', 'groupId': 'OG002', 'lowerLimit': '0.95', 'upperLimit': '4.00'}]}]}, {'title': 'Naldemedine Day 28 (n = 4, 4, 4)', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.97'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '1.03'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.08'}]}]}, {'title': 'Nor-S-297995 Day 1 (n = 9, 5, 9)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not calculable as plasma concentrations of Nor-S-297995 on Day 1 were below the limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '4.03', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '8.00'}]}]}, {'title': 'Nor-S-297995 Day 28 (n = 3, 4, 4)', 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '3.97', 'upperLimit': '8.03'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'Naldemedine Day 1 (n = 6, 8, 7)', 'categories': [{'measurements': [{'value': '8.491', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '15.95', 'spread': '42.6', 'groupId': 'OG001'}, {'value': '30.58', 'spread': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Naldemedine Day 28 (n = 3, 4, 3)', 'categories': [{'measurements': [{'value': '9.677', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '16.94', 'spread': '46.6', 'groupId': 'OG001'}, {'value': '31.72', 'spread': '11.4', 'groupId': 'OG002'}]}]}, {'title': 'Nor-S-297995 Day 1 (n = 9, 8, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculable as plasma concentrations of Nor-S-297995 on Day 1 were below the limit of quantification.', 'groupId': 'OG000'}, {'value': '0.5106', 'spread': '55.5', 'groupId': 'OG001'}, {'value': '2.950', 'spread': '53.8', 'groupId': 'OG002'}]}]}, {'title': 'Nor-S-297995 Day 28 (n = 3, 4, 3)', 'categories': [{'measurements': [{'value': '0.3522', 'spread': '896.9', 'groupId': 'OG000'}, {'value': '0.8158', 'spread': '463.1', 'groupId': 'OG001'}, {'value': '2.256', 'spread': '140.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population with available data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).', 'description': 'Treatment-emergent adverse events (TEAEs) were adverse events that occurred after the first dose of study drug.\n\nTreatment-related TEAEs were defined as TEAEs that were considered by the Investigator to be definitely, probably, or possibly related to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adverse events were assessed using the safety population. The safety population included all participants who received study drug. This population was analyzed as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'FG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'FG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'FG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Use of Prohibited Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other - Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 53 clinical sites in the United States. The first participant was enrolled on August 17, 2011 and the last participant completed on August 22, 2012.\n\nParticipants must have met eligibility criteria and completed the Bowel Movement and Constipation Assessment (BMCA) Diary for a minimum of 14 days to enroll in the study.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1:1 ratio to receive placebo, naldemedine 0.1 mg, 0.2 mg, or 0.4 mg once daily.\n\nOne participant was randomized twice, first to placebo and subsequently to naldemedine 0.4 mg, and is counted in both arms below and for safety analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '238', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.'}, {'id': 'BG001', 'title': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.'}, {'id': 'BG002', 'title': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.'}, {'id': 'BG003', 'title': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '9.71', 'groupId': 'BG001'}, {'value': '50.7', 'spread': '11.40', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '11.19', 'groupId': 'BG003'}, {'value': '51.9', 'spread': '10.80', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≥ 18 - < 40 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}, {'title': '≥ 40 - < 50 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': '≥ 50 - < 65 years', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}, {'title': '≥ 65 - < 75 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': '≥ 75 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Naive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '196', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Spontaneous Bowel Movement (SBM) Frequency per Week', 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.720', 'groupId': 'BG000'}, {'value': '1.51', 'spread': '0.820', 'groupId': 'BG001'}, {'value': '1.52', 'spread': '0.916', 'groupId': 'BG002'}, {'value': '1.20', 'spread': '0.948', 'groupId': 'BG003'}, {'value': '1.36', 'spread': '0.851', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'SBMs/week', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The modified intention-to-treat (mITT) population included all randomized participants who received study drug and had at least 1 postdose primary efficacy assessment completed. One participant who randomized twice was excluded from the naldemedine 0.4 mg arm for the mITT population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2011-09-20', 'resultsFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-19', 'studyFirstPostDateStruct': {'date': '2011-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to randomization.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA BM was defined as all bowel movements observed irrespective of the use of a laxative agent.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA BM was defined as all bowel movements observed irrespective of the use of a laxative agent.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': "Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'"}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': "Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'"}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.'}, {'measure': 'Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM responder was defined as a participant whose frequency of SBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of SBMs from baseline of 1 or more per week.'}, {'measure': 'Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM responder was defined as any participant whose frequency of SBM per week during the treatment period was 3 times or more per week, and who had an average increase from baseline of 1 or more per week.'}, {'measure': 'Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM responder was defined as a participant whose frequency of CSBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week.'}, {'measure': 'Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM responder was defined as a participant whose frequency of CSBMs during the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nAn SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation.'}, {'measure': 'Time to the First Spontaneous Bowel Movement', 'timeFrame': '28 days', 'description': 'Time to the first SBM was defined as the time to the first SBM after the initial administration of study drug. Participants who withdrew from the study before an SBM was observed or had no SBM during the treatment period were treated as censored.'}, {'measure': 'Time to the First Complete Spontaneous Bowel Movement', 'timeFrame': '28 days', 'description': 'Time to the first CSBM was defined as the time to the first CSBM after the initial administration of study drug. Participants who withdrew from the study before a CSBM was observed or had no CSBM during the treatment period were treated as censored.'}, {'measure': 'Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug', 'timeFrame': '4, 8, 12, and 24 hours', 'description': 'The percentage of participants who experienced at least one SBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.'}, {'measure': 'Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug', 'timeFrame': '4, 8, 12, and 24 hours', 'description': 'The percentage of participants who experienced at least one CSBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score of 0 or 1.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining is defined as a BM with a straining score of 0 or 1.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.\n\nA false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted).'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).'}, {'measure': 'Mean Rescue Laxative Use Per Week During the Treatment Period', 'timeFrame': 'Weeks 1 to 4', 'description': 'Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.'}, {'measure': 'Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort', 'timeFrame': 'Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)', 'description': 'Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.'}, {'measure': 'Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort', 'timeFrame': 'Baseline and Weeks 1, 2, 3, and 4', 'description': 'Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.'}, {'measure': 'Subject Global Satisfaction at End of Treatment', 'timeFrame': 'Day 29, or at early termination', 'description': 'On day 29 (or at early termination), participants were asked about their degree of satisfaction with constipation and abdominal symptoms from the start of study drug dosing to Day 28 (or early termination visit). The grades were as follows: 1, markedly worsened; 2, moderately worsened; 3, slightly worsened; 4, unchanged; 5, slightly improved; 6, moderately improved; and 7, markedly improved.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.'}, {'measure': 'Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.'}, {'measure': 'Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)', 'timeFrame': 'Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose', 'description': 'Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).', 'description': 'Treatment-emergent adverse events (TEAEs) were adverse events that occurred after the first dose of study drug.\n\nTreatment-related TEAEs were defined as TEAEs that were considered by the Investigator to be definitely, probably, or possibly related to study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid Therapy', 'Non-Malignant Chronic Pain', 'Opioid-Induced Constipation'], 'conditions': ['Opioid-induced Constipation']}, 'referencesModule': {'references': [{'pmid': '28371937', 'type': 'RESULT', 'citation': 'Webster LR, Yamada T, Arjona Ferreira JC. A Phase 2b, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain. Pain Med. 2017 Dec 1;18(12):2350-2360. doi: 10.1093/pm/pnw325.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation\n* Subjects with \\< 3 spontaneous bowel movements a week and experiencing bowel symptoms\n* Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months\n\nExclusion Criteria:\n\n* Evidence of clinically significant gastrointestinal disease\n* History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation\n* Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation'}, 'identificationModule': {'nctId': 'NCT01443403', 'briefTitle': 'A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy', 'orgStudyIdInfo': {'id': '1107V9221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo orally once daily for 28 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Naldemedine 0.1 mg', 'description': 'Participants received 0.1 mg naldemedine orally once daily for 28 days.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'EXPERIMENTAL', 'label': 'Naldemedine 0.2 mg', 'description': 'Participants received 0.2 mg naldemedine orally once daily for 28 days.', 'interventionNames': ['Drug: Naldemedine']}, {'type': 'EXPERIMENTAL', 'label': 'Naldemedine 0.4 mg', 'description': 'Participants received 0.4 mg naldemedine orally once daily for 28 days.', 'interventionNames': ['Drug: Naldemedine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets administered orally once a day.', 'armGroupLabels': ['Placebo']}, {'name': 'Naldemedine', 'type': 'DRUG', 'otherNames': ['S 297995', 'Symproic®'], 'description': 'Naldemedine tablets administered orally once a day.', 'armGroupLabels': ['Naldemedine 0.1 mg', 'Naldemedine 0.2 mg', 'Naldemedine 0.4 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Sun Lakes', 'state': 'Arizona', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 33.21116, 'lon': -111.87542}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'city': 'Lomita', 'state': 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