Viewing Study NCT00598806

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Ignite Creation Date: 2025-12-26 @ 5:20 PM
Ignite Modification Date: 2026-02-03 @ 9:51 AM
Study NCT ID: NCT00598806
Status: COMPLETED
Last Update Posted: 2017-11-13
First Post: 2008-01-11
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C060817', 'term': 'apaziquone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gajanan.Bhat@sppirx.com', 'phone': '949-743-9219', 'title': 'Gajanan Bhat, PhD', 'organization': 'Spectrum Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'First publication is the multi-center publication of Study results from all study sites. Other than the multi-center publication, site may publish an independent publication of data generated by site subject to Sponsor review rights (e.g., review for intellectual property, confidentiality).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent Adverse Events (ie, AEs that occurred or worsened following the TURBT procedure) were recorded from the time of randomization to Month 6; after Month 6 until Month 24 (end of study), only genitourinary AEs and Serious AEs (SAEs) were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of EOquin® 4mg in 40ml instilled into the bladder post-TURBT', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 313, 'seriousNumAtRisk': 402, 'deathsNumAffected': 14, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT', 'otherNumAtRisk': 410, 'deathsNumAtRisk': 410, 'otherNumAffected': 322, 'seriousNumAtRisk': 410, 'deathsNumAffected': 14, 'seriousNumAffected': 108}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 90}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 62}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 73}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 37}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 39}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 19}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary bladder hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ureteric obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Aortic aneurysm repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Radiotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Radical prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Post procedural hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary retention postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cystocele repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 402, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 410, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Large intestine 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[{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Non-Progression', 'measurements': [{'value': '253', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': "The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.", 'unitOfMeasure': 'months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}, {'type': 'SECONDARY', 'title': 'Number of Recurrences Per Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The number of histologically confirmed recurrences during the course of the study.', 'unitOfMeasure': 'recurrences', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'classes': [{'categories': [{'measurements': [{'value': '22.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': "The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause", 'unitOfMeasure': 'months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}, {'type': 'SECONDARY', 'title': 'Disease-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': "The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause", 'unitOfMeasure': 'months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The number of months from randomization to death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Target Ta, G1-G2 Population: patients who had 4 or fewer tumors that were ≤ 3.5 cm each at the time of randomization and who had subsequent histological confirmation from the central pathology lab that the tumors resected at the time of randomization were Ta, Grade 1 or 2.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}, {'groupId': 'FG001', 'numSubjects': '410'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}, {'groupId': 'FG001', 'numSubjects': '346'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '64'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'BG000'}, {'value': '410', 'groupId': 'BG001'}, {'value': '812', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apaziquone', 'description': 'Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '11.60', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '11.83', 'groupId': 'BG001'}, {'value': '66.7', 'spread': '11.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}]}, {'title': '65-75', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}]}, {'title': '>75', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '599', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '787', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', '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': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '792', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '223', 'groupId': 'BG001'}, {'value': '438', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2013-12-18', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2008-01-11', 'dispFirstSubmitQcDate': '2015-05-26', 'resultsFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2008-01-22', 'dispFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-14', 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence Rate at 2 Years', 'timeFrame': '2 years', 'description': 'The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.'}], 'secondaryOutcomes': [{'measure': 'Time to Recurrence', 'timeFrame': '2 years', 'description': "The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor."}, {'measure': 'Progression Rate at 2 Years', 'timeFrame': '2 years', 'description': 'The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.'}, {'measure': 'Time to Progression', 'timeFrame': '2 years', 'description': "The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor."}, {'measure': 'Number of Recurrences Per Patient', 'timeFrame': '2 years', 'description': 'The number of histologically confirmed recurrences during the course of the study.'}, {'measure': 'Disease-Free Interval', 'timeFrame': '2 years', 'description': "The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause"}, {'measure': 'Disease-Free Survival', 'timeFrame': '2 years', 'description': "The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause"}, {'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'The number of months from randomization to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Noninvasive Bladder Cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.', 'detailedDescription': "This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.\n\nA postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).\n\n* If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \\[WHO\\]/International Society of Urologic Pathology \\[ISUP\\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).\n* If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \\[WHO/ISUP classification\\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).\n\nAll patients were to be followed for 2 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of the following questions must be answered "Yes" in order for the patient to participate in the study.\n\n1. Has the patient given written informed consent?\n2. Is the patient at least 18 years old?\n3. Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2?\n4. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?\n5. If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?\n6. Is the patient willing and able to abide by the protocol?\n\nExclusion Criteria:\n\nAll of the following questions must be answered "No" in order for the patient to participate in the study.\n\n1. Does the patient have more than 5 bladder tumors?\n2. Does any single bladder tumor exceed 3.5 cm in diameter?\n3. Does the patient have a single, primary bladder tumor \\<0.5 cm and has no previous diagnosis of bladder cancer?\n4. Has the patient ever received EOquin(r)?\n5. Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade \\[WHO/ISUP classification\\])?\n6. Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?\n7. Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?\n8. Does the patient have an active urinary tract infection?\n9. Does the patient have a bleeding disorder or a screening platelet count \\< 100 x 109/L?\n10. Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?\n11. Does the patient have screening hemoglobin \\< 10 mg/dL, a screening absolute neutrophil count \\< 1.5 x 109/L?\n12. Does the patient have a known immunodeficiency disorder?\n13. Has the patient received any investigational treatment within the past 30 days?\n14. Is the patient breast feeding?\n15. Does the patient have a history of interstitial cystitis?\n16. Does the patient have a history of allergy to red color food dye?\n17. Has the patient had transitional cell carcinoma of the bladder within the past 4 months?'}, 'identificationModule': {'nctId': 'NCT00598806', 'briefTitle': 'Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)', 'orgStudyIdInfo': {'id': 'SPI-612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apaziquone', 'description': 'TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT', 'interventionNames': ['Drug: Apaziquone', 'Procedure: TURBT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT', 'interventionNames': ['Drug: Placebo', 'Procedure: TURBT']}], 'interventions': [{'name': 'Apaziquone', 'type': 'DRUG', 'otherNames': ['EOquin®, Qapzola'], 'description': 'A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT', 'armGroupLabels': ['Apaziquone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A single intravesical dose of placebo instilled into the bladder post-TURBT', 'armGroupLabels': ['Placebo']}, {'name': 'TURBT', 'type': 'PROCEDURE', 'description': 'TransUrethral Resection of the Bladder Tumor', 'armGroupLabels': ['Apaziquone', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Urology Medical Center Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Hal J. 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