Trial Outcomes & Findings for Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer (NCT NCT00318643)
NCT ID: NCT00318643
Last Updated: 2021-10-29
Results Overview
The MTD was defined as the maximum dose level at which no more than two of six participants experienced dose-limiting toxicities (DLT). DLT was defined as any of the following: * Plasma MMC concentration greater than or equal to (\>=) 100 nanograms (ng)/milliliter (mL) * Adverse event (AE) with a Common Toxicity Criteria (CTC) grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
5 weeks (Week 2 to Week 6)
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
Cohort 1: MMC Plus Chemophase 20,000 U
Participants received 40 milligrams (mg) mitomycin C (MMC) intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 Units (U) Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
12
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
6
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: MMC Plus Chemophase 20,000 U
Participants received 40 milligrams (mg) mitomycin C (MMC) intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 Units (U) Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Participant's Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Investigator's Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: MMC Plus Chemophase 20,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 8.54 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 10.33 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
68.0 years
STANDARD_DEVIATION 10.54 • n=21 Participants
|
67.9 years
STANDARD_DEVIATION 9.44 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 5 weeks (Week 2 to Week 6)Population: The Intent-To-Treat (ITT) Set included all participants who received one or more doses of Chemophase with MMC.
The MTD was defined as the maximum dose level at which no more than two of six participants experienced dose-limiting toxicities (DLT). DLT was defined as any of the following: * Plasma MMC concentration greater than or equal to (\>=) 100 nanograms (ng)/milliliter (mL) * Adverse event (AE) with a Common Toxicity Criteria (CTC) grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Chemophase in Combination With MMC
|
800000 Units
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 weeks (Week 2 to Week 6)Population: ITT Set included all participants who received one or more doses of Chemophase with MMC.
DLT was defined as any of the following: * Plasma MMC concentration \>= 100 ng/mL * AE with a CTC grade greater than or equal to 3 * New, treatment-emergent diagnosis of bladder fibrosis.
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 weeks (Week 2 to Week 6)Population: ITT Set included all participants who received one or more doses of Chemophase with MMC.
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Recommended Dose of Chemophase With MMC For Future Studies
|
800000 Units
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (predose), 1, 2, and 3 hours postdose at Weeks 1, 2, 5, and 6Population: ITT Set included all participants who received one or more doses of Chemophase with MMC.
A quantifiable MMC plasma concentration value was a value that was not below the quantifiable limit (BQL) of \<10.0 nanogram/milliliter (ng/mL).
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 6: 1 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 6: 2 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 1: Predose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 1: 1 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 1: 2 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 1: 3 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 2: Predose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 2: 1 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 2: 2 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 2: 3 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 5: Predose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 5: 1 hour
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 5: 2 hours
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 5: 3 hours
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 6: Predose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Quantifiable MMC Plasma Concentration Value
Week 6: 3 hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: The Safety Set included all participants who received one or more doses of Chemophase.
TEAEs were defined as any AE that occurred after the first administration of the study drug and until the end of the study. AEs were defined as any untoward medical occurrence in a participant administered study drug and that did not necessarily have a causal relationship with the study drug. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: ITT Set included all participants who received one or more doses of Chemophase with MMC.
Outcome measures
| Measure |
Cohort 5: MMC Plus Chemophase 800,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 Participants
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Number of Participants Who Remained Tumor Free at the End of the Study
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
Adverse Events
Cohort 1: MMC Plus Chemophase 20,000 U
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: MMC Plus Chemophase 60,000 U
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: MMC Plus Chemophase 200,000 U
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4: MMC Plus Chemophase 400,000 U
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5: MMC Plus Chemophase 800,000 U
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: MMC Plus Chemophase 20,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
Other adverse events
| Measure |
Cohort 1: MMC Plus Chemophase 20,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 2: MMC Plus Chemophase 60,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 3: MMC Plus Chemophase 200,000 U
n=6 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 4: MMC Plus Chemophase 400,000 U
n=3 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
Cohort 5: MMC Plus Chemophase 800,000 U
n=12 participants at risk
Participants received 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
2/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
2/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
2/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
2/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Renal and urinary disorders
Urtheral haemorrhage
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
General disorders
Malaise
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
General disorders
Suprapubic pain
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
8.3%
1/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Blood urine present
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
False positive laboratory result
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
16.7%
1/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
|
Investigations
White blood cells urine
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/6 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
33.3%
1/3 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
0.00%
0/12 • Baseline up to 2 years
The Safety Set included all participants who received one or more doses of Chemophase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI must submit a copy of the proposed publication to the Sponsor 40 days prior to date of submission for publication. They can request a delay of up to 45 days if it is determined there is any patentable subject matter or confidential Information. Sponsor can make changes to the communication to remove sponsor's confidential information from it prior to publication.
- Publication restrictions are in place
Restriction type: OTHER