Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-08 @ 11:26 PM
Study NCT ID:
NCT03219333
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2017-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014516', 'term': 'Ureteral Neoplasms'}, {'id': 'D014523', 'term': 'Urethral Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D014522', 'term': 'Urethral Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632577', 'term': 'enfortumab vedotin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@seagen.com', 'phone': '(855) 473-2436', 'title': 'Chief Medical Officer', 'organization': 'Seagen Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Cohort 1: maximum up to 62.36 months of follow-up; Cohort 2: maximum up to 48.95 months of follow-up', 'description': 'Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 123, 'seriousNumAtRisk': 125, 'deathsNumAffected': 104, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 88, 'seriousNumAtRisk': 89, 'deathsNumAffected': 72, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 22, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 62, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 42, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 26, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 73, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 52, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 68, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 35, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 71, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 41, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 45, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 19, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 41, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 81, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 43, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 53, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 28, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 59, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 53, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 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{'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 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'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Transitional cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Demyelinating polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Dermatitis bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '53.2'}, {'value': '51.7', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '62.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOR) Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'comment': 'Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '6.34', 'upperLimit': 'NA'}, {'value': '10.9', 'comment': 'Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '5.78', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '4.93', 'upperLimit': '7.46'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.03', 'upperLimit': '8.28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'ORR Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '30.6', 'upperLimit': '48.3'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '39.8', 'upperLimit': '61.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST 1.1. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'DOR Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'comment': 'Upper limit of 95%CI could not be estimated due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '5.95', 'upperLimit': 'NA'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '5.85', 'upperLimit': '16.59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'PFS Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '4.93', 'upperLimit': '7.46'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '5.42', 'upperLimit': '7.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Hemoglobin decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Platelets decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Platelets decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]', 'description': "A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Alanine aminotransferase increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Albumin decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline phosphatase increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Calcium decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Calcium increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Glucose decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.', 'groupId': 'OG001'}]}]}, {'title': 'Glucose increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Potassium decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Potassium decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Potassium increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Sodium decreased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Sodium decreased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sodium increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urate increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Urate increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Amylase increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Amylase increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (all grades)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Lipase increased (grade 3-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]', 'description': 'A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Analysis set. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value."}, {'type': 'SECONDARY', 'title': 'Incidence of Antitherapeutic Antibody (ATA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Baseline Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative post-baseline', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'title': 'Transiently positive post-baseline', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Persistently positive post-baseline', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Negative post-baseline', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Transiently positive post-baseline', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Persistently positive post-baseline', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]', 'description': 'Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if \\>=2 consecutive samples were confirmed as positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Analysis Set: Participants who received at least one dose of enfortumab vedotin. Here, 'Overall Number of Participants Analyzed' signifies ATA subset (participants with a baseline and at least one post-baseline sample). Here, 'Number Analyzed' signifies participants evaluable for specified rows."}, {'type': 'SECONDARY', 'title': 'Disease Control Rate at 16 Weeks (DCR16) Per BICR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '59.5'}, {'value': '58.4', 'groupId': 'OG001', 'lowerLimit': '47.5', 'upperLimit': '68.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 16', 'description': 'Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'DCR16 Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '64.1'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '73.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 16', 'description': 'Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '15.57'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '10.51', 'upperLimit': '18.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]; Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]', 'description': 'OS is defined as the time from first dose of enfortumab vedotin to death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all enrolled participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs): Primary Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Any treatment-emergent AEs (TEAEs)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Any grade 3-5 TEAEs', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related grade 3-5 TEAEs', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Any serious TEAEs', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related serious TEAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAEs leading to death', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]', 'description': 'AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: includes all participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '24.4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '29.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '31.4', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '27.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0278', 'groupId': 'OG000', 'lowerLimit': '0.010', 'upperLimit': '0.052'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.021', 'upperLimit': '0.088'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0285', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.054'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.084'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0264', 'groupId': 'OG000', 'lowerLimit': '0.011', 'upperLimit': '0.042'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.074'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0285', 'groupId': 'OG000', 'lowerLimit': '0.020', 'upperLimit': '0.115'}, {'value': '0.0257', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.047'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': '7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '41.4', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 1, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '43.8', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '46.0', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '32.0', 'spread': '30.0', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '41.2', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '35.8', 'groupId': 'OG001'}]}]}, {'title': '14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '44.7', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '47.5', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-14) - Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': '40.4', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '36.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.', 'unitOfMeasure': 'Day*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '67.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '57.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '64.8', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '57.4', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '60.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '64.8', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '59.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Free MMAE: Tmax (Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '9'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Free MMAE: AUC (Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': '7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '81.7', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '64.1', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 1, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '79.1', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '65.0', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '58.0', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '65.0', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '64.7', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '60.2', 'groupId': 'OG001'}]}]}, {'title': '14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.9', 'spread': '74.7', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '76.4', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-14) - Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '61.2', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '65.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.', 'unitOfMeasure': 'Day*nanogram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, MMAE or Tab concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Overall Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for Total Antibody (TAb): Cmax (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '23.4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.9', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.2', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '28.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for TAb: Tmax (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0278', 'groupId': 'OG000', 'lowerLimit': '0.010', 'upperLimit': '0.052'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.021', 'upperLimit': '0.088'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0285', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.054'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.084'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0264', 'groupId': 'OG000', 'lowerLimit': '0.011', 'upperLimit': '0.042'}, {'value': '0.0264', 'groupId': 'OG001', 'lowerLimit': '0.015', 'upperLimit': '0.074'}]}]}, {'title': 'Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0285', 'groupId': 'OG000', 'lowerLimit': '0.020', 'upperLimit': '0.115'}, {'value': '0.0257', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.047'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'PK Parameter for TAb: AUC (Serum)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': '7-day post-infusion AUC (AUC(d0-7)) - Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.4', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '34.3', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 1, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.6', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '37.9', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-7) - Cycle 2, Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.9', 'spread': '30.6', 'groupId': 'OG000'}, {'value': '81.0', 'spread': '30.9', 'groupId': 'OG001'}]}]}, {'title': '14-day post-infusion AUC (AUC(d0-14)) - Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'spread': '38.8', 'groupId': 'OG000'}, {'value': '91.1', 'spread': '40.3', 'groupId': 'OG001'}]}]}, {'title': 'AUC(d0-14) - Cycle 2, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.0', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '109.7', 'spread': '41.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.', 'unitOfMeasure': 'Day*microgram per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set: all participants who received enfortumab vedotin and from whom at least one blood sample was collected and assayed for enfortumab vedotin, monomethyl auristatin E (MMAE) or total antibody (Tab) concentration. Corresponding records of the time of dosing and sample collection must also be available for all enfortumab vedotin. Here, 'Number Analyzed'= participants evaluable at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs): Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'title': 'Any treatment-emergent AEs (TEAEs)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Any grade 3-5 TEAEs', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related grade 3-5 TEAEs', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Any serious TEAEs', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related serious TEAEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any TEAEs leading to death', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cohort 1: median treatment duration time: 4.60 months (range 0.5, 43.0); Cohort 2: median treatment duration time: 5.98 months (range 0.3 to 25.8)', 'description': 'AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: includes all participants who received at least one dose of enfortumab vedotin.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS): Final Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'OG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '15.57'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '11.24', 'upperLimit': '20.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)', 'description': 'OS is defined as the time from first dose of enfortumab vedotin to death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: includes all enrolled participants who received at least one dose of enfortumab vedotin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'FG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '91'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'Study closed in 2023,as all milestones reached, majority of participants completed 5 years follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Eligible participants with locally advanced or metastatic urothelial cancer who have previously received systemic therapy with a programmed cell death protein-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitor and met inclusion criteria and none of the exclusion criteria were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enfortumab Vedotin - Cohort 1', 'description': 'Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'BG001', 'title': 'Enfortumab Vedotin - Cohort 2', 'description': 'Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '84'}, {'value': '75.0', 'groupId': 'BG001', 'lowerLimit': '49', 'upperLimit': '90'}, {'value': '72.0', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'East Asia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG performance status was used to assess participants disease progression, and ability to carry out daily living activities. 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed \\<50% of the time; 3= In bed \\>50% of the time; 4=100% bedridden; 5=Dead', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received any amount of enfortumab vedotin.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-15', 'size': 951038, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-19T11:55', 'hasProtocol': True}, {'date': '2020-09-17', 'size': 373726, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-26T11:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single-arm, open-label, multi-cohort, multicenter study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04136808', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2017-07-13', 'resultsFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2017-07-13', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-16', 'studyFirstPostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR)', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.'}], 'secondaryOutcomes': [{'measure': 'Duration of Objective Response (DOR) Per BICR', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause, whichever comes first. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. DOR was analyzed using Kaplan-Meier methodology.'}, {'measure': 'Progression-Free Survival (PFS) Per BICR', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.'}, {'measure': 'ORR Per Investigator Assessment', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST 1.1. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'DOR Per Investigator Assessment', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.'}, {'measure': 'PFS Per Investigator Assessment', 'timeFrame': 'Cohort 1: median follow-up time: 10.15 months (range 0.49, 16.46); Cohort 2: median follow up time: 13.4 months (range 0.33 to 29.27)', 'description': 'The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1), or to death due to any cause, whichever comes first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression.'}, {'measure': 'Number of Participants With Treatment-Emergent Laboratory Abnormalities (Hematology)', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]', 'description': "A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening."}, {'measure': 'Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]', 'description': 'A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.'}, {'measure': 'Incidence of Antitherapeutic Antibody (ATA)', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]', 'description': 'Participants who were tested positive for ATA at any time post-baseline were considered to be transiently positive or persistently positive if \\>=2 consecutive samples were confirmed as positive.'}, {'measure': 'Disease Control Rate at 16 Weeks (DCR16) Per BICR', 'timeFrame': 'Up to Week 16', 'description': 'Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'DCR16 Per Investigator Assessment', 'timeFrame': 'Up to Week 16', 'description': 'Percentage of participants with CR, PR, or stable disease (SD) at Week 16 visit. CR is defined as disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR is defined as a \\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. The appearance of one or more new lesions is also considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Overall Survival (OS): Primary Analysis', 'timeFrame': 'Cohort 1 median follow-up time: 28.4 months [range 0.49, 32.62]; Cohort 2 median follow up time: 13.4 months [range 0.33 to 29.27]', 'description': 'OS is defined as the time from first dose of enfortumab vedotin to death from any cause.'}, {'measure': 'Number of Participants With Adverse Events (AEs): Primary Analysis', 'timeFrame': 'The median duration of treatment was 4.60 months for Cohort 1 [range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [range: 0.3, 24.6 months]', 'description': 'AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.'}, {'measure': 'Pharmacokinetics (PK) Parameter for Enfortumab Vedotin: Maximum Concentration (Cmax) (Serum)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for Enfortumab Vedotin: Time to Maximum Concentration (Tmax) (Serum)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for Enfortumab Vedotin: Area Under Concentration-Time Curve (AUC) (Serum)', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.'}, {'measure': 'PK Parameter for Free Monomethyl Auristatin E (MMAE): Cmax (Plasma)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for Free MMAE: Tmax (Plasma)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for Free MMAE: AUC (Plasma)', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.'}, {'measure': 'PK Parameter for Total Antibody (TAb): Cmax (Serum)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Cmax was derived from the PK blood samples collected. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for TAb: Tmax (Serum)', 'timeFrame': 'Collected during cycle 1 and 2 of treatment (each cycle=28 days) at Day 1 pre-dose and end of infusion, Day 3, Day 8 pre-dose and end of infusion, Day 15 pre-dose and end of infusion, Day 17, and Day 22', 'description': 'Tmax was derived from the PK blood samples collected. Time of maximum concentration corresponds to the end of infusion sample time. Day 1 data informed by samples collected on Day 1, Day 3, and Day 8. Day 15 data informed by samples collected on Day 15, Day 17, and Day 22.'}, {'measure': 'PK Parameter for TAb: AUC (Serum)', 'timeFrame': 'AUC0-7 was assessed (in cycles 1 and 2) based on concentration data from Day 1 to Day 8 (pre dose) and AUC0-14 was assessed based on data from D15 (pre dose) to D29 (pre-dose)', 'description': 'AUC was derived from the PK blood samples collected.'}, {'measure': 'Number of Participants With Adverse Events (AEs): Final Analysis', 'timeFrame': 'Cohort 1: median treatment duration time: 4.60 months (range 0.5, 43.0); Cohort 2: median treatment duration time: 5.98 months (range 0.3 to 25.8)', 'description': 'AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.'}, {'measure': 'Overall Survival (OS): Final Analysis', 'timeFrame': 'Cohort 1: median follow-up: 61.0 months (range 59.63, 62.36); Cohort 2: median follow-up time: 45.8 months (range 44.91 to 48.95)', 'description': 'OS is defined as the time from first dose of enfortumab vedotin to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enfortumab vedotin', 'Metastatic Urothelial Cancer', 'ASG-22CE', 'Locally Advanced Urothelial Cancer', 'Antibody-Drug Conjugate', 'Nectin-4', 'Platinum-naïve', 'Cisplatin-ineligible', 'Antineoplastic Agents', 'Drug Therapy', 'ASG-22ME'], 'conditions': ['Carcinoma, Transitional Cell', 'Urinary Bladder Neoplasms', 'Urologic Neoplasms', 'Renal Pelvis Neoplasms', 'Urothelial Cancer', 'Ureteral Neoplasms', 'Urethral Neoplasms']}, 'referencesModule': {'references': [{'pmid': '35168844', 'type': 'DERIVED', 'citation': "McGregor B, O'Donnell PH, Balar A, Petrylak D, Rosenberg J, Yu EY, Quinn DI, Heath EI, Campbell M, Hepp Z, McKay C, Steinberg J, Regnault A, Mazerolle F, Galsky MD. Health-related Quality of Life of Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin after Platinum and PD-1/PD-L1 Inhibitor Therapy: Results from Cohort 1 of the Phase 2 EV-201 Clinical Trial. Eur Urol. 2022 May;81(5):515-522. doi: 10.1016/j.eururo.2022.01.032. Epub 2022 Feb 12."}, {'pmid': '33991512', 'type': 'DERIVED', 'citation': "Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, Stein MN, Necchi A, Kojima T, Harrison MR, Hoon Park S, Quinn DI, Heath EI, Rosenberg JE, Steinberg J, Liang SY, Trowbridge J, Campbell M, McGregor B, Balar AV. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):872-882. doi: 10.1016/S1470-2045(21)00094-2. Epub 2021 May 12."}, {'pmid': '31356140', 'type': 'DERIVED', 'citation': "Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, Galsky MD, Hahn NM, Gartner EM, Pinelli JM, Liang SY, Melhem-Bertrandt A, Petrylak DP. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600. doi: 10.1200/JCO.19.01140. Epub 2019 Jul 29."}]}, 'descriptionModule': {'briefSummary': 'This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.\n\nThis clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer.\n\nThis study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect.\n\nPatients who sign up for this trial must also fall into one of these categories:\n\n* Patients have already received treatment with platinum-containing chemotherapy\n* Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.', 'detailedDescription': 'Japan Pharmaceuticals and Medical Devices Agency (PMDA) has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.\n\nThis study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-naïve. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).\n* Metastatic disease or locally advanced disease that is not resectable.\n* Must have received prior treatment with a CPI in the locally advanced or metastatic urothelial cancer setting. A CPI is defined as a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or within 3 months of therapy completion are eligible.\n* Must either have prior treatment with platinum-containing chemotherapy (Cohort 1) or be platinum-naïve and ineligible for treatment with cisplatin at time of enrollment (Cohort 2).\n* Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.\n* Tumor tissue samples must be available for submission to the sponsor prior to study treatment.\n* Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1).\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 for Cohort 1 or ≤2 for Cohort 2.\n* Anticipated life expectancy of ≥3 months as assessed by the investigator.\n\nExclusion Criteria:\n\n* Ongoing sensory or motor neuropathy Grade ≥2.\n* Active central nervous system (CNS) metastases.\n* Immunotherapy related myocarditis, colitis, uveitis, or pneumonitis.\n* Prior enrollment in an enfortumab vedotin study or prior treatment with other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).\n* Uncontrolled tumor-related pain or impending spinal cord compression.'}, 'identificationModule': {'nctId': 'NCT03219333', 'acronym': 'EV-201', 'briefTitle': 'A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy', 'orgStudyIdInfo': {'id': 'SGN22E-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enfortumab vedotin', 'description': 'Enfortumab vedotin on days 1, 8 and 15 every 28 days', 'interventionNames': ['Drug: Enfortumab vedotin']}], 'interventions': [{'name': 'Enfortumab vedotin', 'type': 'DRUG', 'otherNames': ['ASG-22CE', 'ASG-22ME'], 'description': 'Intravenous (IV) infusion on days 1, 8 and 15 every 28 days', 'armGroupLabels': ['Enfortumab vedotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99503', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Urological Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, PC - HAL', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, PC - HOPE', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center / University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center / Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine - Newport', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Roseville', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Santa Clara', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente South San Francisco', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Center Northern California', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Walnut Creek', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers - 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