Trial Outcomes & Findings for Safety and Efficacy Study of IMSA101 in Refractory Malignancies (NCT NCT04020185)
NCT ID: NCT04020185
Last Updated: 2024-12-11
Results Overview
Highest dose level of IMSA101 at which no more than 1 out of 6 patients experienced a dose limiting toxicity (DLT) during the first cycle (28 days) of therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Cycle 1 (28 days) of therapy
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
Monotherapy 100 μg
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 200 μg
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 400 μg
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 800 μg
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 1200 μg
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Combination Therapy 800 μg
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
Combination Therapy 1200 μg
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
Combination Therapy 2400 μg
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
4
|
7
|
4
|
7
|
7
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
2
|
4
|
4
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
2
|
3
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Monotherapy 100 μg
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 200 μg
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 400 μg
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 800 μg
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 1200 μg
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Combination Therapy 800 μg
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
Combination Therapy 1200 μg
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
Combination Therapy 2400 μg
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an approved ICI administered as per product label.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
2
|
1
|
0
|
1
|
0
|
|
Overall Study
Consent withdrawn
|
1
|
0
|
0
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
Patient in hospice
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Continuing on expanded access
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy Study of IMSA101 in Refractory Malignancies
Baseline characteristics by cohort
| Measure |
Monotherapy 100 μg
n=4 Participants
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 200 μg
n=3 Participants
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 400 μg
n=4 Participants
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 800 μg
n=4 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 1200 μg
n=7 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Combination Therapy 800 μg
n=4 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 1200 μg
n=7 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 2400 μg
n=7 Participants
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Total
n=40 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 12.01 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 2.08 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 4.12 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 6.95 • n=4 Participants
|
65.0 years
STANDARD_DEVIATION 14.29 • n=21 Participants
|
74.0 years
STANDARD_DEVIATION 11.34 • n=8 Participants
|
50.3 years
STANDARD_DEVIATION 10.89 • n=8 Participants
|
63.0 years
STANDARD_DEVIATION 21.53 • n=24 Participants
|
61.4 years
STANDARD_DEVIATION 14.12 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
30 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 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
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days) of therapyPopulation: Number of patients who received at least 3 doses of IMSA101 in Cycle 1 and completed 4 weeks on study, or received at least 1 dose of IMSA101 and experienced a DLT during Cycle 1 per dose.
Highest dose level of IMSA101 at which no more than 1 out of 6 patients experienced a dose limiting toxicity (DLT) during the first cycle (28 days) of therapy.
Outcome measures
| Measure |
Monotherapy 200 μg
n=3 Participants
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 400 μg
n=3 Participants
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 800 μg
n=3 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 1200 μg
n=6 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Combination Therapy 800 μg
n=3 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 1200 μg
n=6 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 2400 μg
n=6 Participants
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Monotherapy 100 μg
n=3 Participants
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 9 monthsThe sum of number of patients with best overall response (complete response, partial response, stable disease or progressive disease) as per RECIST v1.1 until End of Treatment. Tumor response was evaluated at the end of each even numbered cycle (eg. Cycle 2, Cycle 4, etc.) until End of Treatment.
Outcome measures
| Measure |
Monotherapy 200 μg
n=3 Participants
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 400 μg
n=3 Participants
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 800 μg
n=2 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Monotherapy 1200 μg
n=6 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond
|
Combination Therapy 800 μg
n=4 Participants
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 1200 μg
n=5 Participants
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Combination Therapy 2400 μg
n=4 Participants
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered as per product label.
|
Monotherapy 100 μg
n=4 Participants
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Response
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Stable Disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Response
Progressive Disease
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
Adverse Events
Monotherapy 100 μg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Monotherapy 200 μg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Monotherapy 400 μg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Monotherapy 800
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Monotherapy 1200
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Combination Therapy 800 μg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Combination Therapy 1200 μg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Combination Therapy 24000 μg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monotherapy 100 μg
n=4 participants at risk
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 200 μg
n=3 participants at risk
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 400 μg
n=4 participants at risk
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 800
n=4 participants at risk
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 1200
n=7 participants at risk
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Combination Therapy 800 μg
n=4 participants at risk
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
Combination Therapy 1200 μg
n=7 participants at risk
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
Combination Therapy 24000 μg
n=7 participants at risk
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Inguinal hernia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Malignant bowel obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Disease progression
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Asthenia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the CNS
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
Other adverse events
| Measure |
Monotherapy 100 μg
n=4 participants at risk
100 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 200 μg
n=3 participants at risk
200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 400 μg
n=4 participants at risk
400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 800
n=4 participants at risk
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Monotherapy 1200
n=7 participants at risk
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
|
Combination Therapy 800 μg
n=4 participants at risk
800 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
Combination Therapy 1200 μg
n=7 participants at risk
1200 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
Combination Therapy 24000 μg
n=7 participants at risk
2400 μg of IMSA101 injected intra-tumorally weekly on Day 1 for the first 3 week cycles of Cycle 1, and then every 2 weeks during Cycles 2 and beyond.
Plus an ICI administered per product label.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site pain
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
71.4%
5/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
75.0%
3/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Fatigue
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
100.0%
3/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
75.0%
3/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
71.4%
5/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Chills
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site dryness
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site irritation
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site swelling
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Odema peripheral
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
57.1%
4/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Asthenia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Disease progression
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Injection site discomfort
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Performance status decreased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Catheter site rash
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
General disorders
Swelling
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
71.4%
5/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Faeces discolored
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Inguinal hernia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Malignant bowel obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
57.1%
4/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
100.0%
3/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
57.1%
4/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Hyponatraemic seizure
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to CNS
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
50.0%
2/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
42.9%
3/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Eye disorders
Conjunctival haemorrhage
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
33.3%
1/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
28.6%
2/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Vascular disorders
Shock
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
25.0%
1/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/3 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/4 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
0.00%
0/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
14.3%
1/7 • 9 months
AE reporting began at the time of study treatment administration and continued until up to 30 days after the last dose, and ranged from to 28 to 261 days.
|
Additional Information
Vice President of Clinical Operations and Project Management
ImmuneSensor Therapeutics Inc.
Phone: 210-380-5164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place