Trial Outcomes & Findings for Evaluation of NanoDoce® in Participants With Urothelial Carcinoma (NCT NCT03636256)
NCT ID: NCT03636256
Last Updated: 2023-08-14
Results Overview
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
9
|
1
|
5
|
2
|
2
|
7
|
|
Overall Study
COMPLETED
|
1
|
3
|
1
|
8
|
1
|
1
|
0
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
1
|
0
|
4
|
2
|
0
|
5
|
Reasons for withdrawal
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
2
|
1
|
0
|
4
|
2
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=4 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=9 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
n=1 Participants
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
n=5 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
n=7 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Outcome measures
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=4 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=9 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
n=1 Participants
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
n=5 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
n=7 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
|
3 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Months 6, 9, and 12Population: All subjects from the NMIBC Group 1 were evaluated for RFS. No subjects in the MIBC Group 2 or MIBC Group 2 Subset were evaluated for RFS.
No evidence of tumor recurrence or disease progression
Outcome measures
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=4 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=9 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Recurrence Free Survival (RFS)
|
5.1 Months
Standard Deviation 1.79
|
6.7 Months
Standard Deviation 3.10
|
4.7 Months
Standard Deviation 1.10
|
9.6 Months
Standard Deviation 3.31
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 45Population: The muscle invasive bladder cancer (MIBC) (Group 2) and MIBC Group 2 Subset were assessed for disease progression at Day 45. There were two subjects in the 3.75 mg/mL NanoDoce cohort for whom disease status at Day 45 was unknown, and there were two subjects withdrawn from the study prior to analysis of disease progression at Day 45.
Disease progression at Day 45 derived from cytology and biopsy assessments
Outcome measures
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=5 Participants
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=2 Participants
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=3 Participants
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
n=1 Participants
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Progression
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=4 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=3 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=3 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period Maintenance (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=9 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period Maintenance (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
n=1 participants at risk
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
n=5 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
n=2 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
n=2 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
n=7 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation): Subjects received an initial intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Bladder Perforation
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Chest Pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
Other adverse events
| Measure |
Non-Muscle Invasive Bladder Cancer (Group 1) 0.75 mg/mL
n=4 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 1.5 mg/mL
n=3 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 2.5 mg/mL
n=3 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 mg/mL or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period Maintenance (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Non-Muscle Invasive Bladder Cancer (Group 1) 3.75 mg/mL
n=9 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce at 2.0 or 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subjects received intravesical instillations of NanoDoce in an Induction Period (6 weekly NanoDoce intravesical instillations at 2.0 or 3.0 mg/mL, followed by 6 weeks of rest) and a Maintenance Period Maintenance (3 weekly NanoDoce intravesical instillations at 3.0 mg/mL, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL or 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) Subset 3.75 mg/mL
n=1 participants at risk
NanoDoce (direct injection): Subject received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subject received an initial intravesical instillation of NanoDoce at 3.0 mg/mL within 2 hours of direct injection.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations: Subject received intravesical instillations of NanoDoce at 3.0 mg/mL in an Induction Period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest) and a Maintenance Period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). Total dose administered for intravesical instillations could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 0.75 mg/mL
n=5 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 0.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 1.5 mg/mL
n=2 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 1.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 2.5 mg/mL
n=2 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 2.5 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation) - Subjects received an initial intravesical instillation of NanoDoce 2.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 50 mg in 25 mL of saline for a final concentration of 2.0 mg/mL.
|
Muscle Invasive Bladder Cancer (Group 2) 3.75 mg/mL
n=7 participants at risk
NanoDoce (direct injection): Subjects received NanoDoce 3.75 mg/mL (up to 4 mL) injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT).
NanoDoce (intravesical instillation): Subjects received an initial intravesical instillation of NanoDoce 3.0 mg/mL within 2 hours of direct injection. Total dose administered for intravesical instillation could not exceed 75 mg in 25 mL of saline for a final concentration of 3.0 mg/mL.
|
|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Micturition urgency
|
50.0%
2/4 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Polyuria
|
50.0%
2/4 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
3/9 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
2/2 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
2/4 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 6 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Tongue Discoloration
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Asthenia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Chest Pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Chills
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Disease Progression
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
66.7%
6/9 • Number of events 6 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Oedema Peripheral
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Herpes Virus Infection
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
28.6%
2/7 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Culture urine positive
|
25.0%
1/4 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Urine analysis abnormal
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urine abnormality
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
3/9 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
66.7%
2/3 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
66.7%
6/9 • Number of events 6 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Bladder pain
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
22.2%
2/9 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Haematuria
|
50.0%
2/4 • Number of events 6 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
66.7%
2/3 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
3/9 • Number of events 5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
2/2 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
33.3%
1/3 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
11.1%
1/9 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Orthostatic hypotension
|
25.0%
1/4 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
28.6%
2/7 • Number of events 2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Lipase decreased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
100.0%
1/1 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
1/2 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/7 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/3 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/9 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/2 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
14.3%
1/7 • Number of events 1 • AE were captured from first study drug dose (injection) until 45 days after the last study drug dose (injection or instillation) for Group 2 subjects or until the End of Treatment (Visit 13 - Day 180) visit for Group 1 or Group 2 subset subjects. Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Subjects were required to spontaneously report any AEs. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place