Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT03320850
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)', 'description': 'All-Cause Mortality: ITT Analysis Set included all randomized participants. Serious Adverse Events and Other Adverse Events: Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 1: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stage 1: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Stage 1: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stage 1: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 6, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 58, 'otherNumAffected': 10, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 17, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 17, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 16, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 59, 'otherNumAffected': 19, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Instillation site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vulvovaginal mycotic infection', 'notes': 'Number of participants at risk are Female participants as this adverse event is specific to Females.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acetonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urethral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG004', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.534', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '0.539', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '0.521', 'groupId': 'OG002'}, {'value': '-1.52', 'spread': '0.520', 'groupId': 'OG003'}, {'value': '-1.85', 'spread': '0.530', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '2.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.635', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'groupDescription': 'The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '0.59', 'ciUpperLimit': '3.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.633', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'groupDescription': 'The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0600', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '2.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.632', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'groupDescription': 'The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1702', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '2.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.631', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'groupDescription': 'The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat (ITT) Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '60', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}, {'value': '58', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG001', 'title': 'Stage 1: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG002', 'title': 'Stage 1: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG003', 'title': 'Stage 1: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG004', 'title': 'Stage 1: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG005', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG006', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG007', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG008', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG009', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '38', 'groupId': 'OG008'}, {'value': '25', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all randomized and treated participants in Stages 1 and 2.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG004', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.64', 'spread': '0.519', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.514', 'groupId': 'OG001'}, {'value': '-0.86', 'spread': '0.486', 'groupId': 'OG002'}, {'value': '-1.00', 'spread': '0.480', 'groupId': 'OG003'}, {'value': '-1.11', 'spread': '0.492', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.2361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.617', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1985', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '1.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.608', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2923', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '1.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.607', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3769', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '1.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.609', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.'}, {'type': 'SECONDARY', 'title': 'Stage 2: Change From Baseline in the Average Volume Voided Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG001', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG002', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG003', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'OG004', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.61', 'spread': '11.251', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '11.214', 'groupId': 'OG001'}, {'value': '4.61', 'spread': '10.576', 'groupId': 'OG002'}, {'value': '11.28', 'spread': '10.349', 'groupId': 'OG003'}, {'value': '21.94', 'spread': '10.779', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.05', 'ciLowerLimit': '-32.87', 'ciUpperLimit': '18.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.107', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5375', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.00', 'ciLowerLimit': '-33.52', 'ciUpperLimit': '17.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.956', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9173', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.33', 'ciLowerLimit': '-26.47', 'ciUpperLimit': '23.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.764', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4730', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.33', 'ciLowerLimit': '-16.24', 'ciUpperLimit': '34.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.981', 'estimateComment': 'Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the ITT Analysis Set, all randomized participants in Stage 2, with data available for analysis at Baseline and Week 12. As per protocol, this endpoint is only applicable to the Stage 2 arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG001', 'title': 'Stage 1: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG002', 'title': 'Stage 1: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG003', 'title': 'Stage 1: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG004', 'title': 'Stage 1: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG005', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG006', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG007', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG008', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'FG009', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '57'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '60'}, {'groupId': 'FG009', 'numSubjects': '59'}]}, {'type': 'Safety Population', 'comment': 'Safety Population included all participants enrolled in this study who received the study treatment in Stage 1 and Stage 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '57'}, {'groupId': 'FG006', 'numSubjects': '57'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '60'}, {'groupId': 'FG009', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '49'}, {'groupId': 'FG006', 'numSubjects': '50'}, {'groupId': 'FG007', 'numSubjects': '53'}, {'groupId': 'FG008', 'numSubjects': '50'}, {'groupId': 'FG009', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Failure to Meet Randomization Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '383', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG001', 'title': 'Stage 1: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100 units (U) (onabotulinumtoxinA; botulinum toxin Type A) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG002', 'title': 'Stage 1: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG003', 'title': 'Stage 1: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG004', 'title': 'Stage 1: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG005', 'title': 'Stage 2: Placebo + Hydrogel Admixture', 'description': 'BOTOX® matching-placebo and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG006', 'title': 'Stage 2: BOTOX® 100U + Hydrogel Admixture', 'description': 'BOTOX® 100U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG007', 'title': 'Stage 2: BOTOX® 300U + Hydrogel Admixture', 'description': 'BOTOX® 300U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG008', 'title': 'Stage 2: BOTOX® 400U + Hydrogel Admixture', 'description': 'BOTOX® 400U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG009', 'title': 'Stage 2: BOTOX® 500U + Hydrogel Admixture', 'description': 'BOTOX® 500U (onabotulinumtoxinA) and hydrogel admixture administered as a single intravesical instillation on Day 1.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '89', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '55.3', 'spread': '13.2', 'groupId': 'BG004'}, {'value': '57.2', 'spread': '12.2', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Stage 1: Safety Analysis Set included all participants who were randomized and treated.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '294', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '11.17', 'groupId': 'BG005'}, {'value': '60.4', 'spread': '9.93', 'groupId': 'BG006'}, {'value': '59.1', 'spread': '11.33', 'groupId': 'BG007'}, {'value': '59.8', 'spread': '9.10', 'groupId': 'BG008'}, {'value': '60.7', 'spread': '9.38', 'groupId': 'BG009'}, {'value': '59.6', 'spread': '10.20', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '383', 'groupId': 'BG010'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}, {'value': '54', 'groupId': 'BG007'}, {'value': '54', 'groupId': 'BG008'}, {'value': '54', 'groupId': 'BG009'}, {'value': '347', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '36', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '383', 'groupId': 'BG010'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '45', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}, {'value': '55', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}, {'value': '52', 'groupId': 'BG009'}, {'value': '338', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '383', 'groupId': 'BG010'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '80', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}, {'value': '43', 'groupId': 'BG009'}, {'value': '294', 'groupId': 'BG010'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stage 1: Average Number of Urinary Incontinence Episodes (UIE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '89', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '5.8', 'spread': '2.7', 'groupId': 'BG002'}, {'value': '4.4', 'spread': '2.7', 'groupId': 'BG003'}, {'value': '5.3', 'spread': '3.0', 'groupId': 'BG004'}, {'value': '5.5', 'spread': '3.0', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of urinary incontinence episodes per day is the average of the 3-day diary entries.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and treated in Stage 1.'}, {'title': 'Stage 2: Average Number of Urinary Incontinence Episodes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '293', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '3.162', 'groupId': 'BG005'}, {'value': '5.60', 'spread': '4.267', 'groupId': 'BG006'}, {'value': '4.46', 'spread': '2.738', 'groupId': 'BG007'}, {'value': '4.56', 'spread': '3.073', 'groupId': 'BG008'}, {'value': '5.92', 'spread': '3.302', 'groupId': 'BG009'}, {'value': '5.30', 'spread': '3.386', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of urinary incontinence episodes per day is the average of the 3-day diary entries.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.'}, {'title': 'Stage 1: Average Number of Micturition Episodes per Day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '89', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '10.9', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '10.0', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '11.3', 'spread': '2.4', 'groupId': 'BG003'}, {'value': '11.8', 'spread': '2.9', 'groupId': 'BG004'}, {'value': '10.9', 'spread': '2.6', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and treated in Stage 1.'}, {'title': 'Stage 2: Average Number of Micturition Episodes per Day', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '293', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '11.12', 'spread': '3.049', 'groupId': 'BG005'}, {'value': '10.97', 'spread': '2.938', 'groupId': 'BG006'}, {'value': '10.91', 'spread': '2.678', 'groupId': 'BG007'}, {'value': '9.88', 'spread': '2.030', 'groupId': 'BG008'}, {'value': '10.70', 'spread': '2.822', 'groupId': 'BG009'}, {'value': '10.71', 'spread': '2.738', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries.', 'unitOfMeasure': 'episodes per day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.'}, {'title': 'Stage 1: Average Volume Voided per Micturition', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '89', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '189.2', 'spread': '64.1', 'groupId': 'BG000'}, {'value': '189.8', 'spread': '94.0', 'groupId': 'BG001'}, {'value': '182.5', 'spread': '79.3', 'groupId': 'BG002'}, {'value': '150.0', 'spread': '54.7', 'groupId': 'BG003'}, {'value': '199.4', 'spread': '70.0', 'groupId': 'BG004'}, {'value': '180.4', 'spread': '71.9', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Analysis Set included all participants who were randomized and treated in Stage 1.'}, {'title': 'Stage 2: Average Volume Voided per Micturition', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '59', 'groupId': 'BG009'}, {'value': '293', 'groupId': 'BG010'}]}], 'categories': [{'measurements': [{'value': '179.10', 'spread': '59.421', 'groupId': 'BG005'}, {'value': '173.28', 'spread': '66.615', 'groupId': 'BG006'}, {'value': '167.10', 'spread': '67.940', 'groupId': 'BG007'}, {'value': '194.50', 'spread': '67.414', 'groupId': 'BG008'}, {'value': '199.58', 'spread': '74.154', 'groupId': 'BG009'}, {'value': '182.79', 'spread': '68.025', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary.', 'unitOfMeasure': 'mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Analysis Set included all randomized participants in Stage 2. Overall number analyzed is the number of participants with data available for analyses at the Baseline.'}], 'populationDescription': 'Stage 1: Safety Analysis Set included all participants who were randomized and treated; Stage 2: Intent-to-treat (ITT) Analysis Set included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-20', 'size': 1892741, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-21T15:36', 'hasProtocol': True}, {'date': '2019-03-07', 'size': 1810419, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-21T15:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2017-10-23', 'resultsFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-21', 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day', 'timeFrame': 'Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.'}, {'measure': 'Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period', 'timeFrame': 'Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.'}], 'secondaryOutcomes': [{'measure': 'Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day', 'timeFrame': 'Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.'}, {'measure': 'Stage 2: Change From Baseline in the Average Volume Voided Per Micturition', 'timeFrame': 'Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12', 'description': 'Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Overactive Bladder With Urinary Incontinence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://AllerganClinicalTrials.com', 'label': 'Additional information on study locations near you may be found at AllerganClinicalTrials.com.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months\n* Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB\n\nExclusion Criteria:\n\n* Overactive Bladder caused by neurological condition\n* Patient has predominance of stress incontinence\n* History or evidence of pelvic or urological abnormality\n* Prior use of BOTOX for any urological condition'}, 'identificationModule': {'nctId': 'NCT03320850', 'acronym': 'APOLLO', 'briefTitle': 'BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence', 'orgStudyIdInfo': {'id': '1839-201-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100U cohort - BOTOX® plus Hydrogel admixture', 'description': '100U BOTOX® (onabotulinumtoxinA) 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