Trial Outcomes & Findings for A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT (NCT NCT02010203)
NCT ID: NCT02010203
Last Updated: 2020-02-17
Results Overview
To evaluate the safety and tolerability of vesigenurtacel-L
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Up to 3 years.
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Phase I: HS-410 Low Dose
In the open label Phase 1 portion, HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
Phase II: HS-410 Low-Dose Plus BCG
In the Phase 2 portion, HS-410 is given as 1\*10\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410 Plus BCG
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
26
|
26
|
26
|
16
|
|
Overall Study
COMPLETED
|
10
|
17
|
16
|
23
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
10
|
3
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Baseline characteristics by cohort
| Measure |
Phase I: HS-410 Low Dose
n=10 Participants
In the open label Phase 1 portion, HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
Phase II: HS-410 Low-Dose Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
27 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
77 Participants
n=10 Participants
|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 7.495 • n=93 Participants
|
70.5 years
STANDARD_DEVIATION 11.176 • n=4 Participants
|
68.58 years
STANDARD_DEVIATION 11.518 • n=27 Participants
|
70.58 years
STANDARD_DEVIATION 9.047 • n=483 Participants
|
72.50 years
STANDARD_DEVIATION 9.784 • n=36 Participants
|
70.60 years
STANDARD_DEVIATION 10.172 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
86 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
99 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
100 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
26 participants
n=4 Participants
|
26 participants
n=27 Participants
|
26 participants
n=483 Participants
|
16 participants
n=36 Participants
|
104 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years.To evaluate the safety and tolerability of vesigenurtacel-L
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=10 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Phase 1: Safety and Tolerability
Gastrointestinal Disorders
|
3 Participants
|
—
|
—
|
—
|
|
Phase 1: Safety and Tolerability
General Disorders & Administration Site Conditions
|
5 Participants
|
—
|
—
|
—
|
|
Phase 1: Safety and Tolerability
Musculoskeletal & Connective Tissue Disorders
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One yearPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Phase 2: 1-year Disease-Free Survival
|
7 Participants
|
9 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
3 months
|
22 participants
|
19 participants
|
23 participants
|
14 participants
|
|
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
6 months
|
19 participants
|
19 participants
|
22 participants
|
9 participants
|
|
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
12 months
|
18 participants
|
17 participants
|
21 participants
|
4 participants
|
|
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
18 months
|
18 participants
|
16 participants
|
15 participants
|
2 participants
|
|
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
24 months
|
14 participants
|
14 participants
|
12 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
6 Months
|
2 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
12 Months
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
|
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
18 Months
|
2 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
24 Months
|
2 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
3 Months
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate Disease Free Survival at 3, 6, 18 and 24 months
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Disease-free Survival at 3, 6, 18, and 24 Months
3 months
|
22 participants
|
19 participants
|
23 participants
|
14 participants
|
|
Disease-free Survival at 3, 6, 18, and 24 Months
6 months
|
19 participants
|
19 participants
|
22 participants
|
9 participants
|
|
Disease-free Survival at 3, 6, 18, and 24 Months
12 months
|
18 participants
|
17 participants
|
21 participants
|
4 participants
|
|
Disease-free Survival at 3, 6, 18, and 24 Months
18 months
|
17 participants
|
16 participants
|
15 participants
|
2 participants
|
|
Disease-free Survival at 3, 6, 18, and 24 Months
24 months
|
13 participants
|
14 participants
|
12 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate overall Disease Free Survival
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Overall Disease-free Survival
|
18 participants
|
17 participants
|
18 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate overall survival (OS)
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Overall Survival, Expressed as the Number of Participants Alive
|
26 participants
|
26 participants
|
26 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months
12 Month
|
8 participants
|
6 participants
|
10 participants
|
—
|
|
Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months
24 Months
|
8 participants
|
7 participants
|
11 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.
Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization
Outcome measures
| Measure |
Phase I: HS-410 Low Dose
n=26 Participants
HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
|
Phase II: High-Dose HS-410 Plus BCG
n=26 Participants
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 Participants
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 Participants
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|
|
Proportion of Patients Undergoing Cystectomy by 12 and 24 Months
12 Months
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Proportion of Patients Undergoing Cystectomy by 12 and 24 Months
24 Months
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data were not collected as pre-specified in Outcome Measure 10 due to study termination by the Sponsor.
Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected as pre-specified in Outcome Measure 11 due to study termination by the Sponsor.
Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected as pre-specified in Outcome Measure 12 due to study termination by the Sponsor.
Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At screeningPopulation: Data were not collected as pre-specified in Outcome Measure 13 due to study termination by the Sponsor.
Evaluation of pre-treatment tumor tissue for antigen expression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Data were not collected as pre-specified in Outcome Measure 14 due to study termination by the Sponsor.
Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Data were not collected as pre-specified in Outcome Measure 15 due to study termination by the Sponsor.
Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Data were not collected as pre-specified in Outcome Measure 16 due to study termination by the Sponsor.
Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years.Population: Data were not collected as pre-specified in Outcome Measure 17 due to study termination by the Sponsor.
Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy
Outcome measures
Outcome data not reported
Adverse Events
Phase I: HS-410 Low Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase II: HS-410 Low-Dose Plus BCG
Serious events: 8 serious events
Other events: 24 other events
Deaths: 0 deaths
Phase II: High-Dose HS-410 Plus BCG
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase II: Placebo Plus BCG
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase II: High-Dose HS-410
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: HS-410 Low Dose
n=10 participants at risk
In the open label Phase 1 portion, HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
Phase II: HS-410 Low-Dose Plus BCG
n=26 participants at risk
In the Phase 2 portion, HS-410 is given as 1\*10\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410 Plus BCG
n=26 participants at risk
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 participants at risk
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 participants at risk
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Cystoprostatectomy
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Prostate Cancer
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Disease Progression
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Bladder Perforation
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
Other adverse events
| Measure |
Phase I: HS-410 Low Dose
n=10 participants at risk
In the open label Phase 1 portion, HS-410 is given as 1\*10\^6 cells per dose for 12 weekly injections followed by 3 monthly injections.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
Phase II: HS-410 Low-Dose Plus BCG
n=26 participants at risk
In the Phase 2 portion, HS-410 is given as 1\*10\^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410 Plus BCG
n=26 participants at risk
In the Phase 2 portion, HS-410 is given as 1\*10\^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
BCG: Vaccine derived from a live bacterium
|
Phase II: Placebo Plus BCG
n=26 participants at risk
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
|
Phase II: High-Dose HS-410
n=16 participants at risk
In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1\*10\^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410.
HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Eye disorders
Dry Eye
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
15.4%
4/26 • Number of events 6 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
23.1%
6/26 • Number of events 7 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
19.2%
5/26 • Number of events 8 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Asthenia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Chills
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
19.2%
5/26 • Number of events 10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
15.4%
4/26 • Number of events 5 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Fatigue
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
38.5%
10/26 • Number of events 14 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
23.1%
6/26 • Number of events 11 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
15.4%
4/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
18.8%
3/16 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Malaise
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Pain
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
19.2%
5/26 • Number of events 7 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
30.8%
8/26 • Number of events 8 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
23.1%
6/26 • Number of events 7 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Investigations
Blood Urine Present
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Investigations
Hematocrit Decreased
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
18.8%
3/16 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 3 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Bladder Perforation
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Bladder Spasm
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
23.1%
6/26 • Number of events 18 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
34.6%
9/26 • Number of events 11 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
23.1%
6/26 • Number of events 9 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
19.2%
5/26 • Number of events 13 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Lower Urinary Tract Symptoms
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
19.2%
5/26 • Number of events 5 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
15.4%
4/26 • Number of events 19 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 6 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Urinary Retention
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Airway Cough Syndrome
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
11.5%
3/26 • Number of events 5 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
6.2%
1/16 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
7.7%
2/26 • Number of events 2 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
3.8%
1/26 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Injection Site Pain
|
40.0%
4/10 • Number of events 4 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
General disorders
Injection Site Erythema
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Endocrine disorders
Hyperadrenalism
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Eye disorders
Eye Haemorrhage
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Gastrointestinal disorders
Dental Caries
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Nephrolithiasis
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
|
Renal and urinary disorders
Nephropathy
|
10.0%
1/10 • Number of events 1 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/26 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
0.00%
0/16 • AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place