Trial Outcomes & Findings for A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors (NCT NCT04442126)
NCT ID: NCT04442126
Last Updated: 2025-05-23
Results Overview
Frequency and severity of adverse events
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
From baseline to up to 12 weeks post last dose, up to 48 weeks.
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Flat dose level; 0.15mg (Dose Level 1)
|
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Flat dose level; 1.5mg (Dose Level 2)
|
Part A Dose Level 3 NM21-1480-Q2W 8mg
Flat dose level; 8mg (Dose Level 3)
|
Part A Dose Level 4 NM21-1480-Q2W 24mg
Flat dose level; 24mg (Dose Level 4)
|
Part A Dose Level 5 NM21-1480-Q2W 80mg
Flat dose level; 80mg (Dose Level 5)
|
Part A Dose Level 6 NM21-1480-Q2W 240mg
Flat dose level; 240mg (Dose Level 6)
|
Part A Dose Level 7 NM21-1480-Q2W 800mg
Flat dose level; mg800 (Dose Level 7)
|
Part A2 NM21-1480-Q2W
This part of the study consisted of a 1400mg flat dose across one cohort.
|
Part B NM21-1480-Q2W
This part of the study consisted of a 800mg flat dose across three cohorts.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
3
|
6
|
3
|
9
|
5
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
3
|
6
|
3
|
9
|
5
|
21
|
Reasons for withdrawal
| Measure |
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Flat dose level; 0.15mg (Dose Level 1)
|
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Flat dose level; 1.5mg (Dose Level 2)
|
Part A Dose Level 3 NM21-1480-Q2W 8mg
Flat dose level; 8mg (Dose Level 3)
|
Part A Dose Level 4 NM21-1480-Q2W 24mg
Flat dose level; 24mg (Dose Level 4)
|
Part A Dose Level 5 NM21-1480-Q2W 80mg
Flat dose level; 80mg (Dose Level 5)
|
Part A Dose Level 6 NM21-1480-Q2W 240mg
Flat dose level; 240mg (Dose Level 6)
|
Part A Dose Level 7 NM21-1480-Q2W 800mg
Flat dose level; mg800 (Dose Level 7)
|
Part A2 NM21-1480-Q2W
This part of the study consisted of a 1400mg flat dose across one cohort.
|
Part B NM21-1480-Q2W
This part of the study consisted of a 800mg flat dose across three cohorts.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
1
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
2
|
2
|
4
|
1
|
5
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
2
|
10
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Progressive Disease
|
0
|
1
|
3
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part A Dose Level 1NM21-1480-Q2W0.15mg
n=1 Participants
Flat dose level; 0.15mg(Dose Level 1)
|
Part A Dose Level 2NM21-1480-Q2W1.5mg
n=1 Participants
Flat dose level; 1.5mg(Dose Level 2)
|
Part A Dose Level 3NM21-1480-Q2W 8mg
n=3 Participants
Flat dose level; 8mg(Dose Level 3)
|
Part A Dose Level 4NM21-1480-Q2W24mg
n=3 Participants
Flat dose level; 24mg(Dose Level 4)
|
Part A Dose Level 5NM21-1480-Q2W80mg
n=6 Participants
Flat dose level; 80mg(Dose Level 5)
|
Part A Dose Level 6NM21-1480-Q2W240mg
n=3 Participants
Flat dose level; 240mg(Dose Level 6)
|
Part A Dose Level 7NM21-1480-Q2W800mg
n=9 Participants
Flat dose level; mg800(Dose Level 7)
|
Part A2 NM21-1480-Q2W
n=5 Participants
This part of the study consisted of a 1400mgflat dose across one cohort.
|
Part B NM21-1480-Q2W
n=21 Participants
This part of the study consisted of a 800mgflat dose across three cohorts.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
29 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
13 Participants
n=114 Participants
|
32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
20 Participants
n=114 Participants
|
51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
20 Participants
n=114 Participants
|
44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Participant with any TREA
Frequency and severity of adverse events
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=9 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=5 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=21 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
|
1 participants
|
1 participants
|
3 participants
|
3 participants
|
5 participants
|
3 participants
|
9 participants
|
5 participants
|
16 participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days).Population: MTD of NM21-1480 based on Part A and part A2. No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.
To determine the MTD of NM21-1480 based on Part A. Note, No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=26 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=5 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of NM21-1480
|
—
|
—
|
—
|
—
|
—
|
—
|
800 mg
|
1400 mg
|
—
|
PRIMARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=26 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=5 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Determination of Phase 2 Dose of NM21-1480
|
800 mg
|
800 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: The ORR for each given group (dose level, cohort, or arm) in the EAS are summarized according to RECIST 1.1 (and according to iRECIST), accompanied by a 2-sided exact 95% Clopper-Pearson confidence interval (CI).
For best overall response (BOR) and objective response rate (ORR), patients in the Efficacy Analysis Set (EAS) who did not have sufficient on-study tumor assessments to characterize response were included in the denominator when calculating BOR percent and ORR and were thus treated as non-responders.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=9 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=5 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=21 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
To Determine the Anti-tumor Activity (Best Overall Response) of NM21-1480 According to RECIST 1.1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Cmax determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=9 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Maximum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmax)
|
NA ng/mL
Standard Deviation NA
BLQ
|
184.3 ng/mL
Standard Deviation 184.3
|
1604 ng/mL
Standard Deviation 1101
|
6334 ng/mL
Standard Deviation 2331
|
19800 ng/mL
Standard Deviation 5576
|
66890 ng/mL
Standard Deviation 43340
|
204700 ng/mL
Standard Deviation 32070
|
420300 ng/mL
Standard Deviation 12040
|
258500 ng/mL
Standard Deviation 65390
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Cmin determined at C1 for all dose levels with the exception of Part A Dose Level 1 which has been noted as NA ,for which was BLQ. Note: Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=9 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the the Minimum Observed Serum Concentration Determined by Direct Inspection of the Concentration Versus Time Data (Cmin)
|
NA ng/mL
Standard Deviation NA
BLQ
|
0 ng/mL
Standard Deviation 0
|
201.7 ng/mL
Standard Deviation 227.5
|
658.2 ng/mL
Standard Deviation 451.7
|
4203 ng/mL
Standard Deviation 1340
|
15880 ng/mL
Standard Deviation 14540
|
48670 ng/mL
Standard Deviation 17090
|
166000 ng/mL
Standard Deviation 41730
|
54270 ng/mL
Standard Deviation 22000
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Tmax determined at C1 for all dose levels with the exception of Part A Dose Level 1 and Part A Dose Level 2. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=9 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Time From Dosing at Which Cmax is Apparent Determined by Direct Inspection of the Concentration Versus Time Data (Tmax)
|
NA h
BLQ
|
1 h
Interval 1.0 to 1.0
|
26.533 h
Interval 1.0 to 77.58
|
6.407 h
Interval 4.92 to 8.03
|
5.778 h
Interval 0.97 to 25.37
|
2.340 h
Interval 0.95 to 5.05
|
8.720 h
Interval 1.5 to 48.6
|
3.13 h
Interval 1.53 to 8.58
|
1.587 h
Interval 1.53 to 1.7
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Lambda z determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL. The constant Lambda z and its derived parameters meet one of the following conditions: the adjusted regression coefficient is less than 0.8 or the AUC%extrap exceeds 20%.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=5 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=4 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Terminal Phase (Apparent Elimination) Rate Constant (λz)
|
—
|
—
|
—
|
0.007163 1/h
Standard Deviation 0.002300
|
0.005417 1/h
Standard Deviation 0.002940
|
0.003352 1/h
Standard Deviation 0.001460
|
0.003522 1/h
Standard Deviation 0.0007292
|
0.002923 1/h
Standard Deviation 0.001239
|
0.002840 1/h
Standard Deviation 0.0006234
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Assessment of the elimination half-life (t½) determined at C1 for all dose levels with the exception of Part A Dose Level 1, Part A Dose Level 2 and Part A Dose Level 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL. No descriptive statistics determined when fewer than three individual PK parameters are available.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=5 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=4 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Elimination Half-life (t½)
|
—
|
—
|
—
|
102.824 h
Standard Deviation 28.4100
|
165.179 h
Standard Deviation 90.7037
|
230.048 h
Standard Deviation 80.2781
|
203.241 h
Standard Deviation 36.4457
|
272.095 h
Standard Deviation 116.9242
|
253.230 h
Standard Deviation 56.1072
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: AUC0-t determined at C1 for all dose levels with the exception of Part A Dose Level 1 and Part A Dose Level 2. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=9 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Area Under the Serum Concentration-time Curve Extrapolated From the Last Quantifiable Concentration to Infinity Quantifiable Concentration to Infinity (AUC[0-infinity])
|
—
|
—
|
81570 h*ng/mL
Standard Deviation 59740
|
802200 h*ng/mL
Standard Deviation 339000
|
2602000 h*ng/mL
Standard Deviation 1177000
|
9442000 h*ng/mL
Standard Deviation 6364000
|
32630000 h*ng/mL
Standard Deviation 3717000
|
57570000 h*ng/mL
Standard Deviation 12480000
|
39560000 h*ng/mL
Standard Deviation 12150000
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: AUCtau determined at C1 for all dose levels with the exception of Part A Dose Level 1, Part A Dose Level 2 and Part A Dose Level 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=7 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Area Under Serum Concentration-time Curve Over Dosing Interval (AUCtau)
|
—
|
—
|
—
|
803200 h*ng/mL
Standard Deviation 340000
|
2662000 h*ng/mL
Standard Deviation 1022000
|
9648000 h*ng/mL
Standard Deviation 6863000
|
32420000 h*ng/mL
Standard Deviation 3342000
|
69890000 h*ng/mL
Standard Deviation 3413000
|
36810000 h*ng/mL
Standard Deviation 11890000
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Assessment of the clearance (CL) determined at C1 for all dose levels with the exception of Part A Dose Levels 1, 2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=5 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=4 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Clearance (CL)
|
—
|
—
|
—
|
0.03037 L/h
Standard Deviation 0.01332
|
0.03034 L/h
Standard Deviation 0.01764
|
0.02257 L/h
Standard Deviation 0.01329
|
0.01717 L/h
Standard Deviation 0.002606
|
0.01218 L/h
Standard Deviation 0.002768
|
0.01596 L/h
Standard Deviation 0.004527
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Assessment of the volume of distribution (Vd) determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=5 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=8 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=4 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=4 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Volume of Distribution (Vd)
|
—
|
—
|
—
|
4.155 L
Standard Deviation 0.9071
|
5.882 L
Standard Deviation 2.263
|
6.674 L
Standard Deviation 3.379
|
4.952 L
Standard Deviation 0.6848
|
4.454 L
Standard Deviation 0.9507
|
5.930 L
Standard Deviation 2.472
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: A patient is considered positive if they are positive at any scheduled or unscheduled post-baseline assessment.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
n=1 Participants
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
n=1 Participants
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=6 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=3 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=9 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
n=5 Participants
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=21 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of the Frequency of Specific Anti-drug Antibodies to NM21-1480
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Where blank the duration of response was not evaluable.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=1 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
To Determine the Anti-tumor Activity (Duration of Response) of NM21-1480 According to RECIST 1.1
|
—
|
—
|
—
|
1.84 Months
Interval 1.84 to 1.84
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: One patient at dose level 4 exhibited a PR (Partial Response).
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=1 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
To Determine the Anti-tumor Activity (Time-to-response) of NM21-1480 According to RECIST 1.1
|
—
|
—
|
—
|
110 Days
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to up to 12 weeks post last dose, up to 48 weeks.Population: Progression-Free Survival (PFS) is defined as the time from the start of study treatment until the earliest documented date of disease progression or death. \[1\] Q1, Median and Q3 are Kaplan-Meier estimates and the 2-sided 95% confidence interval for median is calculated using the Brookmeyer-Crowley method.
Outcome measures
| Measure |
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
Part A Dose Level 1 NM21-1490-Q2W 0.15mg
|
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
Part A Dose Level 2 NM21-1490-Q2W 1.5mg
|
Part A Dose Level 3 NM21-1490-Q2W 8mg
n=3 Participants
Part A Dose Level 3 NM21-1490-Q2W 8mg
|
Part A Dose Level 4 NM21-1490-Q2W 24mg
n=3 Participants
Part A Dose Level 4 NM21-1490-Q2W 24mg
|
Part A Dose Level 5 NM21-1490-Q2W 80mg
n=5 Participants
Part A Dose Level 5 NM21-1490-Q2W 80mg
|
Part A Dose Level 6 NM21-1490-Q2W 240mg
n=2 Participants
Part A Dose Level 6 NM21-1490-Q2W 240mg
|
Part A Dose Level 7 NM21-1490-Q2W 800mg
n=7 Participants
Part A Dose Level 7 NM21-1490-Q2W 800mg
|
Part A2 NM32-1480-Q2W
Part A2 NM32-1480-Q2W 1400mg
|
Part B NM32-1480-Q2W
n=19 Participants
Part B NM32-1480-Q2W 800mg
|
|---|---|---|---|---|---|---|---|---|---|
|
To Determine the Anti-tumor Activity (Progression-free Survival) of NM21-1480 According to RECIST 1.1
|
—
|
—
|
1.84 Months
Interval 1.708 to 3.253
|
5.49 Months
Interval 5.454 to 5.552
|
1.81 Months
Interval 0.657 to 9.002
|
7.28 Months
Interval 3.548 to 11.006
|
2.86 Months
Interval 1.314 to 7.261
|
—
|
1.41 Months
Interval 0.0526 to 2.727
|
Adverse Events
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A Dose Level 3 NM21-1480-Q2W 8mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Dose Level 4 NM21-1480-Q2W 24mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Dose Level 5 NM21-1480-Q2W 80mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Dose Level 6 NM21-1480-Q2W 240mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Dose Level 7 NM21-1480-Q2W 800mg
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Part A2 NM21-1480-Q2W
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B NM21-1480-Q2W
Serious events: 6 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
n=1 participants at risk
Flat dose level; 0.15mg (Dose Level 1)
|
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
n=1 participants at risk
Flat dose level; 1.5mg (Dose Level 2)
|
Part A Dose Level 3 NM21-1480-Q2W 8mg
n=3 participants at risk
Flat dose level; 8mg (Dose Level 3)
|
Part A Dose Level 4 NM21-1480-Q2W 24mg
n=3 participants at risk
Flat dose level; 24mg (Dose Level 4)
|
Part A Dose Level 5 NM21-1480-Q2W 80mg
n=6 participants at risk
Flat dose level; 80mg (Dose Level 5)
|
Part A Dose Level 6 NM21-1480-Q2W 240mg
n=3 participants at risk
Flat dose level; 240mg (Dose Level 6)
|
Part A Dose Level 7 NM21-1480-Q2W 800mg
n=9 participants at risk
Flat dose level; mg800 (Dose Level 7)
|
Part A2 NM21-1480-Q2W
n=5 participants at risk
This part of the study consisted of a 1400mg flat dose across one cohort.
|
Part B NM21-1480-Q2W
n=21 participants at risk
This part of the study consisted of a 800mg flat dose across three cohorts.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
n=1 participants at risk
Flat dose level; 0.15mg (Dose Level 1)
|
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
n=1 participants at risk
Flat dose level; 1.5mg (Dose Level 2)
|
Part A Dose Level 3 NM21-1480-Q2W 8mg
n=3 participants at risk
Flat dose level; 8mg (Dose Level 3)
|
Part A Dose Level 4 NM21-1480-Q2W 24mg
n=3 participants at risk
Flat dose level; 24mg (Dose Level 4)
|
Part A Dose Level 5 NM21-1480-Q2W 80mg
n=6 participants at risk
Flat dose level; 80mg (Dose Level 5)
|
Part A Dose Level 6 NM21-1480-Q2W 240mg
n=3 participants at risk
Flat dose level; 240mg (Dose Level 6)
|
Part A Dose Level 7 NM21-1480-Q2W 800mg
n=9 participants at risk
Flat dose level; mg800 (Dose Level 7)
|
Part A2 NM21-1480-Q2W
n=5 participants at risk
This part of the study consisted of a 1400mg flat dose across one cohort.
|
Part B NM21-1480-Q2W
n=21 participants at risk
This part of the study consisted of a 800mg flat dose across three cohorts.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
60.0%
3/5 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
19.0%
4/21 • Number of events 4 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
19.0%
4/21 • Number of events 4 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
40.0%
2/5 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
14.3%
3/21 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
General disorders
Ascites
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
14.3%
3/21 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Investigations
Thyroxine increased
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
14.3%
3/21 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
14.3%
3/21 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmondry embolism
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Covid-19
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Chlongitis infective
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Stoma site abscess
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
22.2%
2/9 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
3/9 • Number of events 3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Hypothyroidism
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
66.7%
2/3 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Hyperthyroidism
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
4.8%
1/21 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
20.0%
1/5 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Eye disorders
Diabetic retinal odema
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
9.5%
2/21 • Number of events 2 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
33.3%
1/3 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/9 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/3 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
11.1%
1/9 • Number of events 1 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/5 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
0.00%
0/21 • Up to 3 years.
The safety population included all participants enrolled in the study who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place