Trial Outcomes & Findings for Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611) (NCT NCT00461591)

NCT ID: NCT00461591

Last Updated: 2021-03-30

Results Overview

The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 802 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2021-03-30

Participant Flow

Participant milestones

Measure	Apaziquone Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Study STARTED	406	396
Overall Study COMPLETED	317	311
Overall Study NOT COMPLETED	89	85

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-611)

Baseline characteristics by cohort

Measure	Apaziquone n=406 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=396 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT	Total n=802 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 10.92 • n=5 Participants	68.2 years STANDARD_DEVIATION 10.72 • n=7 Participants	67.8 years STANDARD_DEVIATION 10.82 • n=5 Participants
Age, Customized Age · <65	159 Participants n=5 Participants	146 Participants n=7 Participants	305 Participants n=5 Participants
Age, Customized Age · 65-75	140 Participants n=5 Participants	139 Participants n=7 Participants	279 Participants n=5 Participants
Age, Customized Age · >75	107 Participants n=5 Participants	111 Participants n=7 Participants	218 Participants n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	102 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Male	298 Participants n=5 Participants	294 Participants n=7 Participants	592 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	393 Participants n=5 Participants	379 Participants n=7 Participants	772 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	392 Participants n=5 Participants	383 Participants n=7 Participants	775 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	381 participants n=5 Participants	375 participants n=7 Participants	756 participants n=5 Participants
Region of Enrollment Poland	25 participants n=5 Participants	21 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 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.

The percentage of participants with histologically confirmed recurrence of the bladder tumor at any time after randomization and on or before year 2.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Recurrence Rate at 2 Years Recurrence	112 Participants	121 Participants
Recurrence Rate at 2 Years Non-Recurrence	183 Participants	150 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Time to Recurrence	18.3 months Standard Error 0.47	16.7 months Standard Error 0.55

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The percentage of participants that progress to either a higher stage or grade from the histologically confirmed stage and grade at time of randomization.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Progression Rate at 2 Years Progression	30 Participants	39 Participants
Progression Rate at 2 Years Non-Progression	265 Participants	232 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of months from randomization to progression to either a higher stage or grade of the patient's bladder tumor.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Time to Progression	22.9 months Standard Error 0.26	22.0 months Standard Error 0.34

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of histologically confirmed recurrences during the course of the study.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Number of Recurrences Per Patient	0.6 times Standard Deviation 1.03	0.9 times Standard Deviation 1.21

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of months from randomization to histologically confirmed progression of the patient's bladder tumor or death from any cause

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Disease Free Interval	22.9 months Standard Error 0.26	22.0 months Standard Error 0.34

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of months from randomization to histologically confirmed recurrence of the patient's bladder tumor or death from any cause

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Disease Free Survival	18.0 months Standard Error 0.48	16.4 months Standard Error 0.55

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of months from randomization to death from any cause.

Outcome measures

Measure	Apaziquone n=295 Participants Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=271 Participants Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Overall Survival	20.3 months Standard Error 0.13	23.7 months Standard Error 0.14

Adverse Events

Apaziquone

Serious events: 93 serious events

Other events: 312 other events

Deaths: 11 deaths

Placebo

Serious events: 98 serious events

Other events: 285 other events

Deaths: 13 deaths

Serious adverse events

Measure	Apaziquone n=406 participants at risk Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=396 participants at risk Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Blood and lymphatic system disorders Anemia of chronic disease	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Bradycardia	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Cardiac arrest	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Cardiac tamponade	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Coronary artery stenosis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Sinus bradycardia	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Cardiac disorders Ventricular fibrillation	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Abdominal pain	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Diarrhea	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Duodenal ulcer	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Ileus	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Intestinal perforation	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Large intestine polyp	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Nausea	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Renal and urinary disorders Hematuria	1.5% 6/406 • 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.	2.0% 8/396 • 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.
Cardiac disorders Atrial Fibrillation	1.5% 6/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Pneumonia	1.2% 5/406 • 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.	1.8% 7/396 • 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.
Cardiac disorders Cardiac Failure Congestive	1.2% 5/406 • 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.	1.5% 6/396 • 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.
General disorders Chest Pain	1.2% 5/406 • 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.	1.0% 4/396 • 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.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.2% 5/406 • 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.	1.0% 4/396 • 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.
Infections and infestations Cellulitis	1.2% 5/406 • 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.	0.76% 3/396 • 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.
Surgical and medical procedures Hip Arthroplasty	0.99% 4/406 • 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.	0.51% 2/396 • 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.
Cardiac disorders Coronary Artery Disease	0.74% 3/406 • 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.	1.5% 6/396 • 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.
Surgical and medical procedures Knee Arthroplasty	0.74% 3/406 • 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.	1.0% 4/396 • 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.
Cardiac disorders Myocardial Infarction	0.74% 3/406 • 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.	0.76% 3/396 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.74% 3/406 • 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.	0.76% 3/396 • 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.
Nervous system disorders Syncope	0.74% 3/406 • 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.	0.51% 2/396 • 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.
Renal and urinary disorders Urinary Bladder Hemorrhage	0.74% 3/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Urinary Tract Infection	0.49% 2/406 • 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.	1.3% 5/396 • 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.
Infections and infestations Sepsis	0.49% 2/406 • 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.	0.76% 3/396 • 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.
Renal and urinary disorders Renal Failure Acute	0.49% 2/406 • 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.	0.51% 2/396 • 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.
Cardiac disorders Acute Myocardial Infarction	0.49% 2/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Dehydration	0.49% 2/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Back Pain	0.49% 2/406 • 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.	0.25% 1/396 • 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.
Nervous system disorders Transient Ischemic Attack	0.49% 2/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Acute Coronary Syndrome	0.49% 2/406 • 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.	0.00% 0/396 • 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.
General disorders Death	0.49% 2/406 • 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.	0.00% 0/396 • 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.
Hepatobiliary disorders Cholecystitis Acute	0.49% 2/406 • 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.	0.00% 0/396 • 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.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.49% 2/406 • 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.	0.00% 0/396 • 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.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.25% 1/406 • 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.	0.76% 3/396 • 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.
Gastrointestinal disorders Small Intestinal Obstruction	0.25% 1/406 • 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.	0.51% 2/396 • 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.
Nervous system disorders Cerebrovascular Accident	0.25% 1/406 • 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.	0.51% 2/396 • 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.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.25% 1/406 • 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.	0.51% 2/396 • 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.
Blood and lymphatic system disorders Iron deficiency anemia	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Atrioventricular block complete	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Subdural hematoma	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Toxicity to various agents	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumor	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Renal and urinary disorders Urinary retention	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Surgical and medical procedures Cardiac rehabilitation therapy	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Vascular disorders Aortic aneurysm	0.25% 1/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/406 • 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.	0.51% 2/396 • 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.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/406 • 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.	0.51% 2/396 • 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.
Renal and urinary disorders Calculus ureteric	0.00% 0/406 • 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.	0.51% 2/396 • 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.
Vascular disorders Hypotension	0.00% 0/406 • 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.	0.51% 2/396 • 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.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Gastrointestinal disorders Vomiting	0.25% 1/406 • 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.	0.00% 0/396 • 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.
General disorders Asthenia	0.25% 1/406 • 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.	0.00% 0/396 • 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.
General disorders Ischemic ulcer	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Hepatobiliary disorders Cholecystitis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Immune system disorders Anaphylactic reaction	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Abdominal wall abscess	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Appendicitis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Bronchitis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Gastroenteritis viral	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Infections and infestations Influenza	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Ankle fracture	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Incisional hernia	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Post procedural hematuria	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Procedural nausea	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Procedural pain	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Metabolism and nutrition disorders Electrolyte imbalance	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Musculoskeletal and connective tissue disorders Muscular weakness	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage I	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Carotid artery disease	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Cerebrospinal fluid retention	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Dementia Alzheimer's type	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Dizziness	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Encephalopathy	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Hepatic encephalopathy	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Partial seizures	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Status epilepticus	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Nervous system disorders Subarachnoid hemorrhage	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Psychiatric disorders Bipolar disorder	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Psychiatric disorders Completed suicide	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Renal and urinary disorders Nephrolithiasis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Renal and urinary disorders Renal colic	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Renal and urinary disorders Ureteric obstruction	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Skin and subcutaneous tissue disorders Diabetic foot	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Skin and subcutaneous tissue disorders Psoriasis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Abdominal hernia repair	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Angioplasty	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Aortic aneurysm repair	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Aortic valve replacement	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Carotid endarterectomy	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Coronary arterial stent insertion	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Mitral valve replacement	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Penile prosthesis insertion	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Salpingo-oophorectomy	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Surgical and medical procedures Spinal fusion surgery	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Vascular disorders Labile hypertension	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Vascular disorders Peripheral artery aneurysm	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Vascular disorders Thrombophlebitis	0.25% 1/406 • 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.	0.00% 0/396 • 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.
Blood and lymphatic system disorders Anemia	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Atrial tachycardia	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Cardiac perforation	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Cardiopulmonary failure	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Palpitations	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Cardiac disorders Ventricular tachycardia	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Eye disorders Cataract	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Colitis ischemic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Duodenal ulcer hemorrhage	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Gallstone ileus	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Pancreatic mass	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Rectal prolapse	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Gastrointestinal disorders Retroperitoneal hemorrhage	0.00% 0/406 • 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.	0.25% 1/396 • 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.
General disorders Generalised oedema	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Appendicitis perforated	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Brain abscess	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Cystitis	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Herpes zoster	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Osteomyelitis	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Peritonitis	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Post procedural hemorrhage	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Injury, poisoning and procedural complications Seroma	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Cachexia	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary tract neoplasm	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Nervous system disorders Cerebral hemorrhage	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Nervous system disorders Nerve compression	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Psychiatric disorders Agitation	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Psychiatric disorders Anxiety	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Psychiatric disorders Suicide attempt	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Renal and urinary disorders Acute prerenal failure	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Renal and urinary disorders Bladder perforation	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Renal and urinary disorders Renal failure chronic	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Renal and urinary disorders Renal impairment	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Surgical and medical procedures Bladder neoplasm surgery	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Surgical and medical procedures Radical prostatectomy	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Surgical and medical procedures Ventriculo-peritoneal shunt	0.00% 0/406 • 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.	0.25% 1/396 • 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.
Vascular disorders Hypertension	0.00% 0/406 • 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.	0.25% 1/396 • 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.

Other adverse events

Measure	Apaziquone n=406 participants at risk Apaziquone: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT	Placebo n=396 participants at risk Placebo: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Infections and infestations Urinary tract infection	17.2% 70/406 • 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.	14.6% 58/396 • 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.
Injury, poisoning and procedural complications Procedural pain	7.6% 31/406 • 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.	6.8% 27/396 • 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.
Renal and urinary disorders Bladder pain	5.4% 22/406 • 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.	4.5% 18/396 • 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.
Renal and urinary disorders Bladder spasm	7.1% 29/406 • 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.	5.8% 23/396 • 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.
Renal and urinary disorders Dysuria	18.2% 74/406 • 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.	16.9% 67/396 • 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.
Renal and urinary disorders Haematuria	9.4% 38/406 • 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.	14.4% 57/396 • 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.
Renal and urinary disorders Micturition urgency	7.6% 31/406 • 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.	9.3% 37/396 • 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.
Renal and urinary disorders Pollakiuria	9.6% 39/406 • 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.	11.6% 46/396 • 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.
Renal and urinary disorders Urinary retention	4.2% 17/406 • 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.	7.6% 30/396 • 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.
Gastrointestinal disorders Nausea	3.9% 16/406 • 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.	4.8% 19/396 • 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.

Additional Information

Gajanan Bhat, PhD

Spectrum Pharmaceuticals

Phone: 949-743-9219

Email: Gajanan.Bhat@sppirx.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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).
• Publication restrictions are in place

Restriction type: OTHER