Trial Outcomes & Findings for Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer (NCT NCT03081858)
NCT ID: NCT03081858
Last Updated: 2025-06-27
Results Overview
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-06-27
Participant Flow
Participant milestones
| Measure |
TSD-001 Administration Part 1, Cohort 1
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 2, Cohort 1
In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route.
During part 2, cohort 1, 6 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 2, Cohort 2
In part 2, cohort 2, the dose was selected as the MDD, established in part 1, and provided weekly via the intravesical route.
During part 2, cohort 2, 3 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
TSD-001 Administration Part 1, Cohort 1
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 2, Cohort 1
In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route.
During part 2, cohort 1, 6 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 2, Cohort 2
In part 2, cohort 2, the dose was selected as the MDD, established in part 1, and provided weekly via the intravesical route.
During part 2, cohort 2, 3 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
|---|---|---|---|---|
|
Overall Study
Sponsor Discontinuation - IP issue for investigation (Bacterial Endotoxin level)
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 2, Cohort 1
n=6 Participants
In part 2, cohort 1, the MDD of 360 mg, established in part 1, was provided weekly via the intravesical route.
During part 2, cohort 1, 6 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 6 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
TSD Administration Part 2, Cohort 2
n=3 Participants
In part 2, cohort 1, the MDD of 360 mg, established in part 1, was provided weekly via the intravesical route.
During part 2, cohort 2, 3 additional subjects received intravesical instillations of TSD-001 via urethral catheterization of the urinary bladder at the MDD established in part 1 at weekly intervals for 8 consecutive weeks. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
TSD-001: Administered via intravesical instillation.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
75.33 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
71.67 years
STANDARD_DEVIATION 5.51 • n=7 Participants
|
57.50 years
STANDARD_DEVIATION 16.99 • n=5 Participants
|
64.33 years
STANDARD_DEVIATION 17.79 • n=4 Participants
|
65.27 years
STANDARD_DEVIATION 14.85 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/ Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/ Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/ Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Non-Muscle Invasive Bladder Cancer Recurrent
Yes
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Non-Muscle Invasive Bladder Cancer Recurrent
No
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Number of Tumor Locations
Solitary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Number of Tumor Locations
Multifocal
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Previous Intravesical Therapy
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Previous Intravesical Therapy
No
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
European Association of Urology (EAU) Risk Stratification
Low Risk
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
European Association of Urology (EAU) Risk Stratification
Intermediate Risk
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: MITT/PK Population
Dose immediately preceding the dose at which DLT occurs or when a MDD is reached.
Outcome measures
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg
For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg
For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg
For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg
For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg
For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg
For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg
For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg
For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg
For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg
For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Tolerated Dose or Maximum Deliverable Dose (MDD)
|
NA mg
MTD and/or MDD was not reached in dose escalation in Part 1, Cohort 1 patient treatments.
|
360 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeks (Cohort 1) or 15 weeks (Cohort 2)Population: Per Protocol (PP) Population: The PP population will include subjects in the MITT population who have no major protocol violations. Note: Modified Intent-to-Treat (MITT) population includes all enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.
Determine the marker lesion response rate at final assessment visit for subjects that received the MDD established in part 1.
Outcome measures
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=5 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg
For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg
For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg
For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg
For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg
For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg
For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg
For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg
For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg
For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg
For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Marker Lesion Response Rate
Complete Response
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Marker Lesion Response Rate
Partial Response
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Marker Lesion Response Rate
Marker Lesion Response
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Per Protocol (PP) Population: The PP population will include subjects in the MITT population who have no major protocol violations. Note: Modified Intent-to-Treat (MITT) population includes all enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.
Determine the local (bladder urine) and systemic (peripheral blood) paclitaxel concentrations before and after intravesical exposure to TSD-001 at all doses. Blood and urine samples were collected 15 (± 15) minutes before and 2 hours (± 10 minutes) after each instillation. Results are presented for different dose levels administered during dose escalation. The remaining results are grouped by cohort.
Outcome measures
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg
n=3 Participants
For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg
n=3 Participants
For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg
n=3 Participants
For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg
n=1 Participants
For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg
n=3 Participants
For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg
n=3 Participants
For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg
n=3 Participants
For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg
n=3 Participants
For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg
n=3 Participants
For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg
n=3 Participants
For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Determine Paclitaxel Concentrations
Predose Urine - Paclitaxel Concentration in Urine collected 15 minutes before
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
|
0 ug/L
Standard Deviation 0
|
.8 ug/L
Standard Deviation 1.4
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
|
Part 1: Determine Paclitaxel Concentrations
Postdose Urine - Paclitaxel Concentration in Urine collected 2 hrs post
|
19367 ug/L
Standard Deviation 4341
|
72933 ug/L
Standard Deviation 50497
|
189667 ug/L
Standard Deviation 73433
|
287333 ug/L
Standard Deviation 134016
|
436000 ug/L
|
446000 ug/L
|
241000 ug/L
Standard Deviation 35539
|
699000 ug/L
Standard Deviation 272567
|
686667 ug/L
Standard Deviation 167861
|
1161667 ug/L
Standard Deviation 760795
|
1800000 ug/L
Standard Deviation 606300
|
1886333 ug/L
Standard Deviation 1317354
|
|
Part 1: Determine Paclitaxel Concentrations
Predose Plasma - Paclitaxel Concentration in Plasma collected 15 minutes before
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
|
0 ug/L
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
|
Part 1: Determine Paclitaxel Concentrations
Postdose Plasma - Paclitaxel Concentration in Plasma collected 2 hrs post
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
|
0 ug/L
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Week 2 (pre and post dose)Population: Per Protocol (PP): This population will include subjects in the MITT population who have no major protocol violations. Note: The Modified Intent to Treat (MITT) population includes enrolled subjects who received at least one dose of study drug and have at least one post-baseline measurement of paclitaxel concentration.
Determine the systemic (peripheral blood) paclitaxel concentrations 15 (± 15) minutes before, and 2 hours (± 10 minutes) after the third intravesical instillation (Week 2) of TSD-001.
Outcome measures
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=5 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg
For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg
For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg
For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg
For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg
For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg
For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg
For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg
For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg
For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg
For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Determine Paclitaxel Concentrations
Predose
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Determine Paclitaxel Concentrations
Postdose
|
0 ug/L
Standard Deviation 0
|
0 ug/L
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: The MITT population will include all enrolled subjects who received at least one dose of study drug and had at least one post-baseline measurement of paclitaxel concentration.
Long-term follow-up to determine when histological tissue diagnosis evidence of recurrence occurs for subjects after complete TURBT and exposure to TSD-001 in part 1. Cystoscopic surveillance was performed every 3 months from the last endoscopic assessment in part 1 until 24 months (from initial TURBT and instillation). Part 2 subjects, different than part 1 subjects, were followed for marker lesion response and did not have standardized TURBT timing to use as a baseline and so are not included in these reported RFS rates. Recurrence-free survival is no histological evidence of transitional cell carcinoma (TCC) recurrence in the time outlined for the TCC risk level.
Outcome measures
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 Participants
Part 1, Cohort 1: For the first 3 subjects enrolled, the initial dose was 10 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As Dose Limiting Toxicity(DLT) did not develop, intravesical instillation 14 days later was titrated up according to the schedule (25, 50, 75, 100, 150 mg in SWFI).
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 2
n=3 Participants
Part 1, Cohort 2: For the next 3 subjects enrolled, the initial dose was 90 mg in SWFI. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). As DLT did not develop, intravesical instillation 14 days later was titrated up according to the schedule (180, 270, 360, 450, and 540 mg in SWFI).
As no DLT was observed in the first 6 subjects (cohorts 1 and 2) after titration up, the maximum deliverable dose (MDD) was defined as 360 mg and the dose was recommended for part 2 of the study.
TSD-001: Administered via intravesical instillation.
|
TSD-001 Administration Part 1, Cohort 1: Week 4: 50 mg
For these subjects, the third dose was 50 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 6: 75 mg
For these subjects, the fourth dose was 75 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 8: 100 mg
For these subjects, the fifth dose was 100 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 1: Week 10: 150 mg
For these subjects, the sixth dose was 150 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Day 1: 90 mg
For these subjects, the initial dose was 90 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 2: 180 mg
For these subjects, the second dose was 180 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 4: 270 mg
For these subjects, the third dose was 270 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 6: 360 mg
For these subjects, the fourth dose was 360 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 8: 450 mg
For these subjects, the fifth dose was 450 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
TSD-001 Administration Part 1, Cohort 2: Week 10: 540 mg
For these subjects, the sixth dose was 540 mg in Sterile Water for Injection (SWFI). TSD-001 was planned to be retained in the bladder for 1 hour or more (up to 2 hours) as acceptable, depending on the subject's tolerability of the procedure.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months
One Year · Disease-Free
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months
One Year · Recurrence Occurred
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months
Two Year · Disease-Free
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 3: Rates of Recurrence/Disease-Free Survival in Part 1 Subjects Only at 12 and 24 Months
Two Year · Recurrence Occurred
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
TSD-001 Administration Part 1, Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TSD-001 Administration Part 1, Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TSD-001 Administration Part 2, Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TSD-001 Administration Part 2, Cohort 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
TD-001 Part 3 (Long-term Surveillance)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 participants at risk
In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 1, Cohort 2
n=3 participants at risk
In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 2, Cohort 1
n=6 participants at risk
In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for six doses.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 2, Cohort 2
n=3 participants at risk
In part 2, cohort 2, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for eight doses.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
|
TD-001 Part 3 (Long-term Surveillance)
n=10 participants at risk
All subjects in part 1 and part 2, were eligible for continued surveillance for safety event for up to 2 years after initial intravesical exposure to TSD-001. This observational study of safety (all subjects) and recurrence (Part 1 subjects only) followed standard of care cystoscopy bladder tumor follow-up every 3 months. During this time, only SAEs and those AEs related to SAEs were tracked and recorded.
|
|---|---|---|---|---|---|
|
Infections and infestations
acute pyelonephritis
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Renal and urinary disorders
Extraperitoneal Bladder abscess
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
10.0%
1/10 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
Other adverse events
| Measure |
TSD-001 Administration Part 1, Cohort 1
n=3 participants at risk
In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 1, Cohort 2
n=3 participants at risk
In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 2, Cohort 1
n=6 participants at risk
In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for six doses.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
|
TSD-001 Administration Part 2, Cohort 2
n=3 participants at risk
In part 2, cohort 2, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for eight doses.
TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure).
|
TD-001 Part 3 (Long-term Surveillance)
n=10 participants at risk
All subjects in part 1 and part 2, were eligible for continued surveillance for safety event for up to 2 years after initial intravesical exposure to TSD-001. This observational study of safety (all subjects) and recurrence (Part 1 subjects only) followed standard of care cystoscopy bladder tumor follow-up every 3 months. During this time, only SAEs and those AEs related to SAEs were tracked and recorded.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
10.0%
1/10 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
66.7%
4/6 • Number of events 4 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
General disorders
Fatigue
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
50.0%
3/6 • Number of events 4 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
2/6 • Number of events 3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 2 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
50.0%
3/6 • Number of events 4 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Investigations
Blood urine present
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 2 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Renal and urinary disorders
Calculus bladder
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
33.3%
1/3 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
16.7%
1/6 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/10 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Extraperitoneal Bladder Abscess
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
10.0%
1/10 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
|
Infections and infestations
Abdominal Pain
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/6 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
0.00%
0/3 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
10.0%
1/10 • Number of events 1 • For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least 90 days before the proposed submission for publication/presentation of Study data or findings, the PI will provide the Sponsor with a manuscript for review. No release of confidential information without the Sponsor's written approval. Multi-center results to be published conjointly under Sponsor's direction, but if this final manuscript has not been published within 12 months after study end at all sites, the PI may publish results, subject to contract confidentiality.
- Publication restrictions are in place
Restriction type: OTHER