Trial Outcomes & Findings for Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma (NCT NCT03658304)

NCT ID: NCT03658304

Last Updated: 2024-11-05

Results Overview

The bladder tumor recurrence rate will be measured by the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-11-05

Participant Flow

Participant milestones

Measure	Mitomycin C Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Mitomycin C n=29 Participants Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	70.14 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: all 29 subjects enrolled have reached the 1 year post-surgery timepoint.

The bladder tumor recurrence rate will be measured by the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy

Outcome measures

Measure	Mitomycin C n=29 Participants Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Bladder Tumor Recurrence Rate	41.37 percentage of subjects

SECONDARY outcome

Timeframe: 3 years

Determine the median time to bladder tumor recurrence. A subject is considered to have had a bladder tumor recurrence when they have been confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy.

Outcome measures

Measure	Mitomycin C n=29 Participants Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Time to Bladder Tumor Recurrence	464 days Interval 210.0 to Upper confidence interval is not estimable because an insufficient number of subjects had a recurrence.

SECONDARY outcome

Timeframe: 3 years

Determine the percentage of subjects who are confirmed by bladder biopsy to have a recurrence of urothelial carcinoma in the bladder following nephroureterectomy 3 years post-operatively.

Outcome measures

Measure	Mitomycin C n=29 Participants Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Percentage of Subjects Who Had a Bladder Tumor Recurrence 3 Years Post-operatively	58.62 percentage of subjects

Adverse Events

Mitomycin C

Serious events: 1 serious events

Other events: 27 other events

Deaths: 4 deaths

Serious adverse events

Measure

Mitomycin C n=29 participants at risk Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.

General disorders Fever

3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.

Other adverse events

Measure	Mitomycin C n=29 participants at risk Mitomycin c: All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
Ear and labyrinth disorders Vertigo	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Vomiting	17.2% 5/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Nausea	13.8% 4/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Anemia	13.8% 4/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Injury, poisoning and procedural complications Wound complication	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Creatinine increased	20.7% 6/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Edema limbs	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Diarrhea	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Nervous system disorders Dizziness	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Hematuria	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Hypercapnia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Vascular disorders Hypotension	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Melena	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Psychiatric disorders Delirium	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyperglycemia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypophosphatemia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Infections and infestations Urinary tract infection	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Blood and lymphatic system disorders Phlebitis	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary retention	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyperkalemia	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Constipation	13.8% 4/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
General disorders Fatigue	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Abdominal distension	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Back pain	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations Urine output decreased	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypocalcemia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Musculoskeletal and connective tissue disorders Muscle weakness	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Bloating	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Cellulitis	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hyponatremia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Respiratory, thoracic and mediastinal disorders Hiccups	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Surgical and medical procedures Pain	6.9% 2/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Metabolism and nutrition disorders Hypomagnesemia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Investigations White blood cell decreased	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Cardiac disorders Sinus tachycardia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Acute kidney injury	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Cardiac disorders Chest pain	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Dyspepsia	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders GI upset	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Gastrointestinal disorders Gastrointestinal pain	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Skin and subcutaneous tissue disorders Pruritis	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
Renal and urinary disorders Urinary frequency	3.4% 1/29 • Adverse event data were collected, at a minimum, from the time of informed consent until 30 days after mitomycin C instillation. Adverse event data were collected for a maximum of 1,057 days for all participants. Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator from the time of informed consent until 30 days after mitomycin c instillation at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.

Additional Information

Allison Allegra

University of Florida

Phone: 352-294-5691

Email: allisonallegra3@ufl.edu

Results disclosure agreements

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