Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00284518
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, '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': {'description': 'Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.', 'otherNumAtRisk': 94, 'otherNumAffected': 41, 'seriousNumAtRisk': 94, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.', 'otherNumAtRisk': 93, 'otherNumAffected': 46, 'seriousNumAtRisk': 93, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.', 'otherNumAtRisk': 94, 'otherNumAffected': 53, 'seriousNumAtRisk': 94, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.', 'otherNumAtRisk': 92, 'otherNumAffected': 55, 'seriousNumAtRisk': 92, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatic specific antigen increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Retinal artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Corneal degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bacterial prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.3', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '5.80', 'groupId': 'OG001'}, {'value': '21.5', 'spread': '5.42', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '5.44', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=86,89,93,90)', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '7.13', 'groupId': 'OG001'}, {'value': '-6.6', 'spread': '6.87', 'groupId': 'OG002'}, {'value': '-5.5', 'spread': '6.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.3', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '5.80', 'groupId': 'OG001'}, {'value': '21.5', 'spread': '5.42', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '5.44', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 72 (N=64,61,66,58)', 'categories': [{'measurements': [{'value': '-5.0', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '7.15', 'groupId': 'OG002'}, {'value': '-4.3', 'spread': '7.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'description': 'The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Urine Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.4', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '2.57', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 12 (N=81,80,86,77)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '4.98', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '5.21', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '4.74', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline to Week 72 (N=59,56,64,53)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '5.18', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '4.07', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '4.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.', 'unitOfMeasure': 'milliliters (mL)/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Prostate Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.78', 'spread': '16.800', 'groupId': 'OG000'}, {'value': '48.40', 'spread': '16.325', 'groupId': 'OG001'}, {'value': '47.54', 'spread': '16.917', 'groupId': 'OG002'}, {'value': '47.23', 'spread': '14.867', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=86,84,88,82)', 'categories': [{'measurements': [{'value': '-3.40', 'spread': '10.046', 'groupId': 'OG000'}, {'value': '-3.65', 'spread': '9.255', 'groupId': 'OG001'}, {'value': '-3.54', 'spread': '9.823', 'groupId': 'OG002'}, {'value': '-4.59', 'spread': '8.392', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 72 (N=65,60,67,57)', 'categories': [{'measurements': [{'value': '-3.58', 'spread': '9.773', 'groupId': 'OG000'}, {'value': '-2.82', 'spread': '11.194', 'groupId': 'OG001'}, {'value': '-1.77', 'spread': '10.714', 'groupId': 'OG002'}, {'value': '-2.69', 'spread': '10.875', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Transitional Zone Prostate Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.78', 'spread': '14.657', 'groupId': 'OG000'}, {'value': '21.75', 'spread': '12.931', 'groupId': 'OG001'}, {'value': '21.00', 'spread': '14.188', 'groupId': 'OG002'}, {'value': '20.73', 'spread': '13.210', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=83,82,86,79)', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '6.516', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '8.085', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '8.445', 'groupId': 'OG002'}, {'value': '-0.27', 'spread': '6.551', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 72 (N=64,59,65,55)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '7.655', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '8.119', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '8.808', 'groupId': 'OG002'}, {'value': '-1.35', 'spread': '6.801', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'milliliters (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-Void Residual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '91', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '73.0', 'spread': '57.07', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '54.93', 'groupId': 'OG001'}, {'value': '66.1', 'spread': '55.59', 'groupId': 'OG002'}, {'value': '64.3', 'spread': '51.89', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 2 (N=76,82,80,78)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '64.06', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '88.62', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '65.01', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '61.03', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=88,84,89,82)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '78.18', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '81.23', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '62.82', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '57.92', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 72 (N=66,60,65,60)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '73.27', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '54.31', 'groupId': 'OG001'}, {'value': '14.0', 'spread': '75.97', 'groupId': 'OG002'}, {'value': '6.0', 'spread': '69.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 12, Week 72', 'description': 'Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'milliliters (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the safety population (includes all randomized and treated participants) with data available for analyses at the given time-point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.4', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '10.19', 'groupId': 'OG002'}, {'value': '16.7', 'spread': '10.29', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=80,72,83,79)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '6.66', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '5.54', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '6.93', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '7.86', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 72 (N=61,54,61,58)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '4.56', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '7.34', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '7.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population (includes all randomized participants) with data available for analyses at the given time-point.'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in IPSS at Week 12 in Patients Previously Treated With Alpha-blockers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'OG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.3', 'spread': '6.20', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '6.15', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '5.65', 'groupId': 'OG002'}, {'value': '20.4', 'spread': '5.32', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline at Week 12 (N=44,35,52,42)', 'categories': [{'measurements': [{'value': '-5.1', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '5.91', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '5.17', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '6.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The International Prostate Symptom Score (IPSS) is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population previously treated with alpha-blockers with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'FG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'FG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'FG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '380', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.'}, {'id': 'BG001', 'title': 'Botulinum Toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.'}, {'id': 'BG002', 'title': 'Botulinum Toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.'}, {'id': 'BG003', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '45 to 65 Years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '194', 'groupId': 'BG004'}]}]}, {'title': '>65 Years', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '186', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '380', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2010-02-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2006-01-31', 'dispFirstSubmitQcDate': '2010-02-03', 'resultsFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2006-01-31', 'dispFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-16', 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72', 'timeFrame': 'Baseline, Week 72', 'description': 'The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Peak Urine Flow Rate', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Total Prostate Volume', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Transitional Zone Prostate Volume', 'timeFrame': 'Baseline, Week 12, Week 72', 'description': 'Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Post-Void Residual', 'timeFrame': 'Baseline, Week 2, Week 12, Week 72', 'description': 'Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '23098762', 'type': 'DERIVED', 'citation': 'Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower urinary tract symptoms due to benign prostatic hyperplasia\n* Enlarged prostate volume by rectal ultrasound\n\nExclusion Criteria:\n\n* Previous prostate surgery\n* Previous or current diagnosis of prostate cancer\n* Use of other medications for the treatment of prostatic hyperplasia\n* Urinary tract infection'}, 'identificationModule': {'nctId': 'NCT00284518', 'briefTitle': 'Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A 300 U', 'description': 'Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A 200 U', 'description': 'Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A 100 U', 'description': 'Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal Saline) transperineal or transrectal injection on Day 1.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®'], 'description': 'Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.', 'armGroupLabels': ['botulinum toxin Type A 100 U', 'botulinum toxin Type A 200 U', 'botulinum toxin Type A 300 U']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Normal Saline (Placebo) transperineal or transrectal injection on Day 1.', 'armGroupLabels': ['Placebo (Normal Saline)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murdoch', 'country': 'Australia', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Braunschweig', 'country': 'Germany', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'city': 'Perugia', 'country': 'Italy', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Martin', 'country': 'Slovakia', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}