Trial Outcomes & Findings for A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (NCT NCT04688931)
NCT ID: NCT04688931
Last Updated: 2024-06-06
Results Overview
DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to high-grade (HG) disease, or death due to any cause. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
282 participants
Primary outcome timeframe
15 months
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
UGN-102 ± TURBT
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
140
|
|
Overall Study
COMPLETED
|
123
|
106
|
|
Overall Study
NOT COMPLETED
|
19
|
34
|
Reasons for withdrawal
| Measure |
UGN-102 ± TURBT
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
16
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Noncompliance
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Randomization Error
|
3
|
0
|
|
Overall Study
Not Eligible
|
1
|
3
|
|
Overall Study
Disease Progression
|
0
|
2
|
|
Overall Study
Sponsor Requirement
|
1
|
1
|
|
Overall Study
Other Reason
|
1
|
2
|
Baseline Characteristics
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
UGN-102 ± TURBT
n=142 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=140 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
91 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
277 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
11 participants
n=5 Participants
|
20 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
37 participants
n=5 Participants
|
26 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
44 participants
n=5 Participants
|
47 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s)
Yes
|
54 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s)
No
|
88 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s) Within 1 Year
Yes
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Previous LG-NMIBC Episode(s) Within 1 Year
No
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Prior TURBT(s)
Yes
|
52 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Prior TURBT(s)
No
|
90 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Tumor Size
≤ 3 cm
|
69 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Tumor Size
> 3 cm
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Tumor Size
Missing
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Tumor Count
Multiple
|
82 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Tumor Count
Single
|
54 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Tumor Count
Missing
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Smoking History
Non-smoker
|
63 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Smoking History
Smoker
|
79 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: All randomized patients regardless of whether the treatment was administered.
DFS is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), progression to high-grade (HG) disease, or death due to any cause. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=142 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=140 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Disease-free Survival (DFS)
|
72.0 percentage of participants
Interval 63.1 to 79.2
|
49.5 percentage of participants
Interval 39.6 to 58.6
|
SECONDARY outcome
Timeframe: 15 monthsPopulation: All randomized patients regardless of whether the treatment was administered.
TTR is defined as the time from randomization until the earliest date of any of the following events: failure to be rendered free of local disease at the 3-month Visit (TURBT arm only), recurrence of LG disease after the 3-month Visit (ie, during the Follow-up Period), or progression to HG disease. Summarized is the Kaplan-Meier estimated probability of remaining event-free at 15 months from randomization.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=142 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=140 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Time to Recurrence (TTR)
|
72.0 percentage of participants
Interval 63.1 to 79.2
|
50.3 percentage of participants
Interval 40.4 to 59.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized patients regardless of whether the treatment was administered. At the time of the 3-month Visit, patients had received only the primary intervention (6 weekly intravesical instillations of UGN-102 starting on Day 1 or TURBT on Day 1).
CRR is defined as the percentage of patients who achieve CR at the 3-month Visit.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=142 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=140 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Complete Response Rate (CRR)
|
64.8 percentage of participants
Interval 56.3 to 72.6
|
63.6 percentage of participants
Interval 55.0 to 71.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All patients who achieved CR at the 3-month disease assessment. Patients who achieved CR at 3 months received only the primary intervention (6 weekly intravesical instillations of UGN-102 starting on Day 1 or TURBT on Day 1).
DOR is defined as the time from first documented CR until the earliest date of recurrence of LG disease, progression to HG disease, or death due to any cause. DOR applies only to patients who achieve CR at the 3-month Visit. Summarized is the Kaplan-Meier estimated probability of remaining in response at 12 months after 3-month CR.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=92 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=89 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Duration of Response (DOR)
|
79.7 percentage of participants
Interval 69.3 to 86.9
|
67.7 percentage of participants
Interval 55.8 to 77.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: All patients who achieved CR at the 3-month disease assessment. Patients who achieved CR at 3 months received only the primary intervention (6 weekly intravesical instillations of UGN-102 starting on Day 1 or TURBT on Day 1).
Observed CRR at scheduled disease assessment time points is defined as the percentage of patients who achieve CR at the 3-month Visit and maintain CR up to a particular follow-up visit. Summarized is the observed percentage of patients remaining in response at 3, 6, 9, and 12 months after 3-month CR.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=92 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=89 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Observed CRR at Scheduled Disease Assessment Time Points
3 Months After 3-Month CR
|
92.4 percentage of participants
Interval 84.9 to 96.9
|
71.9 percentage of participants
Interval 61.4 to 80.9
|
|
Observed CRR at Scheduled Disease Assessment Time Points
6 Months After 3-Month CR
|
80.4 percentage of participants
Interval 70.9 to 88.0
|
62.9 percentage of participants
Interval 52.0 to 72.9
|
|
Observed CRR at Scheduled Disease Assessment Time Points
9 Months After 3-Month CR
|
75.0 percentage of participants
Interval 64.9 to 83.4
|
57.3 percentage of participants
Interval 46.4 to 67.7
|
|
Observed CRR at Scheduled Disease Assessment Time Points
12 Months After 3-Month CR
|
71.7 percentage of participants
Interval 61.4 to 80.6
|
55.1 percentage of participants
Interval 44.1 to 65.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients who received any dose of UGN-102 (treatment arm) or at least one TURBT intervention (control arm).
Number of TURBTs is defined as the average number of per protocol TURBTs per patient in each arm. Per protocol TURBTs are defined as the Day 1 TURBT for patients in the TURBT alone arm and TURBT due to residual LG disease at the 3-month disease assessment in either arm.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=138 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=132 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Number of TURBTs
|
0.2 TURBT procedures
Standard Deviation 0.38
|
1.1 TURBT procedures
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Pre-treatment to 3 months after the start of treatmentPopulation: All patients who received any dose of UGN-102 (treatment arm) or at least one TURBT intervention (control arm). At the time of the 3-month Visit, patients had received only the primary intervention (6 weekly intravesical instillations of UGN-102 starting on Day 1 or TURBT on Day 1).
The European Organisation for Research and Treatment of Cancer (EORTC) 24-item quality of life questionnaire for patients with NMIBC (QLQ-NMIBC24) is a patient-reported instrument that assesses 11 domains (urinary symptoms, malaise, future worries, bloating and flatulence, intravesical treatment issues, sexual intimacy, risk of contaminating partner, male sexual problems, female sexual problems, sexual function, and sexual enjoyment). All of the domains range in score from 0 to 100 with lower scores reflecting better functioning/quality of life and higher scores reflecting worse functioning/quality of life. Summarized is the change from baseline in domain scores at the 3-month Visit. Changes in domain scores were calculated for patients with non-missing answers at both time points.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=138 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=132 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Changes From Baseline in Health-related Quality of Life
Urinary Symptoms
|
-10.7 score on a scale
Standard Deviation 17.88
|
-4.5 score on a scale
Standard Deviation 20.04
|
|
Changes From Baseline in Health-related Quality of Life
Malaise
|
-4.4 score on a scale
Standard Deviation 13.58
|
-1.1 score on a scale
Standard Deviation 16.41
|
|
Changes From Baseline in Health-related Quality of Life
Intravesical Treatment Issues
|
-4.0 score on a scale
Standard Deviation 25.61
|
-2.9 score on a scale
Standard Deviation 25.09
|
|
Changes From Baseline in Health-related Quality of Life
Future Worries
|
-12.7 score on a scale
Standard Deviation 26.49
|
-8.3 score on a scale
Standard Deviation 26.74
|
|
Changes From Baseline in Health-related Quality of Life
Bloating and Flatulence
|
-7.7 score on a scale
Standard Deviation 18.03
|
-3.0 score on a scale
Standard Deviation 16.68
|
|
Changes From Baseline in Health-related Quality of Life
Male Sexual Problems
|
0.9 score on a scale
Standard Deviation 32.99
|
-0.6 score on a scale
Standard Deviation 30.75
|
|
Changes From Baseline in Health-related Quality of Life
Sexual Intimacy
|
0.0 score on a scale
Standard Deviation 19.86
|
3.6 score on a scale
Standard Deviation 30.12
|
|
Changes From Baseline in Health-related Quality of Life
Risk of Contaminating Partner
|
1.6 score on a scale
Standard Deviation 26.12
|
0.0 score on a scale
Standard Deviation 16.80
|
|
Changes From Baseline in Health-related Quality of Life
Female Sexual Problems
|
-10.0 score on a scale
Standard Deviation 16.10
|
-8.9 score on a scale
Standard Deviation 15.26
|
|
Changes From Baseline in Health-related Quality of Life
Sexual Function
|
0.4 score on a scale
Standard Deviation 18.02
|
-1.6 score on a scale
Standard Deviation 22.20
|
|
Changes From Baseline in Health-related Quality of Life
Sexual Enjoyment
|
8.7 score on a scale
Standard Deviation 36.97
|
-1.0 score on a scale
Standard Deviation 32.26
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: All patients who received any dose of UGN-102 (treatment arm) or at least one TURBT intervention (control arm).
The number of patients with each type of event will be summarized. TEAEs were defined as adverse events (AEs) that occurred on or after the day of first instillation of UGN-102 for patients in the UGN-102 ± TURBT arm or the day of initial TURBT for patients in the TURBT alone arm, or pre-treatment events that worsened during the study.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=138 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=132 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
Any TEAEs
|
104 Participants
|
63 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
Any serious TEAEs
|
12 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
Any TEAEs of special interest
|
78 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All patients who received any dose of UGN-102 (treatment arm) or at least one TURBT intervention (control arm) and who had non-missing laboratory values at the specified time.
The number of patients with each type of event will be summarized.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=138 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=126 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline
|
4 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
Leukocytes ≤ 2.8 × 10^3/μL
|
4 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
Leukocytes ≥ 16.0 × 10^3/μL
|
1 Participants
|
0 Participants
|
|
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
Platelets < 75 × 10^3/μL
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: All patients who received any dose of UGN-102 (treatment arm) or at least one TURBT intervention (control arm) and who had non-missing laboratory values at the specified time.
The number of patients with each type of event will be summarized.
Outcome measures
| Measure |
UGN-102 ± TURBT
n=138 Participants
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=126 Participants
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Potassium > 5.5 mEq/L
|
18 Participants
|
10 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Sodium ≤ 130 mEq/L
|
2 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Sodium > 150 mEq/L
|
2 Participants
|
0 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Alanine aminotransferase > 3 × upper limit of normal (ULN)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Aspartate aminotransferase > 3 × ULN
|
2 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Bilirubin > 1.5 × ULN
|
3 Participants
|
2 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Creatinine > 2.2 mg/dL
|
0 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Gamma glutamyl transferase > 2.5 × ULN
|
5 Participants
|
1 Participants
|
|
Number of Participants With Post-baseline PCS Serum Chemistry Values
Potassium < 3.0 mEq/L
|
0 Participants
|
1 Participants
|
Adverse Events
UGN-102 ± TURBT
Serious events: 12 serious events
Other events: 102 other events
Deaths: 0 deaths
TURBT Alone
Serious events: 7 serious events
Other events: 62 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
UGN-102 ± TURBT
n=138 participants at risk
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=132 participants at risk
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
2.9%
4/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
1.5%
2/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Infections and infestations
Pneumonia
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Infections and infestations
Sepsis
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
1.5%
2/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
1.5%
2/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.76%
1/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.76%
1/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.76%
1/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.72%
1/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.76%
1/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.76%
1/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
Other adverse events
| Measure |
UGN-102 ± TURBT
n=138 participants at risk
6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).
|
TURBT Alone
n=132 participants at risk
TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).
|
|---|---|---|
|
Renal and urinary disorders
Dysuria
|
30.4%
42/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
4.5%
6/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Micturition urgency
|
18.1%
25/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
7.6%
10/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Nocturia
|
18.1%
25/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
6.8%
9/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Pollakiuria
|
15.9%
22/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
6.1%
8/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Renal and urinary disorders
Haematuria
|
6.5%
9/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.8%
5/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
13/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.0%
4/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
6/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.0%
4/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Infections and infestations
COVID-19
|
5.1%
7/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
4.5%
6/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Infections and infestations
Cystitis
|
3.6%
5/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.8%
5/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
4/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.8%
5/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
General disorders
Malaise
|
5.8%
8/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
1.5%
2/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
General disorders
Fatigue
|
3.6%
5/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
General disorders
Pyrexia
|
3.6%
5/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
0.00%
0/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.5%
9/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.0%
4/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Nervous system disorders
Headache
|
4.3%
6/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
1.5%
2/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/138 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
3.0%
4/132 • Up to 21 months
Per protocol, sites were instructed to report AEs that occurred from the signing of the informed consent form to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment (UGN-102 or TURBT) or study procedures were to be reported until the End of Study Visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place