Trial Outcomes & Findings for Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT05216835)
NCT ID: NCT05216835
Last Updated: 2025-10-02
Results Overview
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Results posted on
2025-10-02
Participant Flow
Participants were enrolled in this study from 18 March 2022 (First subject in) and the analyses presented in this results form are based on a final data cut-off (DCO) of 30 August 2024.
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment. Part B was not initiated, therefore, no participant was enrolled and analyzed for this part of the study.
Participant milestones
| Measure |
Cohort A1
Participants with relapsed or refractory classical Hodgkin Lymphoma (r/r cHL) previously treated with anti-programmed cell death protein-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) based therapy received 2mg of sabestomig.
|
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
5
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
5
|
12
|
12
|
12
|
Reasons for withdrawal
| Measure |
Cohort A1
Participants with relapsed or refractory classical Hodgkin Lymphoma (r/r cHL) previously treated with anti-programmed cell death protein-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) based therapy received 2mg of sabestomig.
|
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Ongoing as of DCO (30 Aug 2024)
|
0
|
0
|
0
|
0
|
3
|
10
|
10
|
9
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=7 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
NA Years
STANDARD_DEVIATION NA • n=4 Participants
|
45.8 Years
STANDARD_DEVIATION 17.6 • n=21 Participants
|
44.4 Years
STANDARD_DEVIATION 16.0 • n=8 Participants
|
38.6 Years
STANDARD_DEVIATION 14.5 • n=8 Participants
|
52.1 Years
STANDARD_DEVIATION 21.2 • n=24 Participants
|
44.0 Years
STANDARD_DEVIATION 17.4 • n=42 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
|
Sex/Gender, Customized
All
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)Population: Safety set included all participants who received any amount of study intervention. CTCAE = Common Terminology Criteria for Adverse Events (version 5.0) 1. = As assessed by the investigator. 2. = AE of special interest derivations were programmed based on sponsor assessment of AE terms.
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE with outcome = death, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any SAE (including events with outcome = death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any SAE (including events with outcome = death), possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any SAE leading to discontinuation of Sabestomig
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any SAE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE leading to discontinuation of Sabestomig
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE possibly related to Sabestomig [a]
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of CTCAE grade 3 or higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of CTCAE grade 3 or higher, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE with outcome = death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE leading to cycle delay
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE leading to cycle delay, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of special interest [b]
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of special interest [b] also considered as an immune-mediated AE [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of special interest [b], possibly related to Sabestomig [a]
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any AE of special interest [b] also an immune-mediated AE, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any immune-mediated AE [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)
Any immune-mediated AE, possibly related to Sabestomig [a]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]Population: Safety set included all participants who received any amount of study intervention.
DLT was defined as any ≥Grade 3 AE as per NCI CTCAE version 5 unless unequivocally due to underlying malignancy or an extraneous cause. The following conditions were considered as DLTs: * Any death not clearly due to the underlying disease or extraneous causes * Grade 4 imAE or anemia * Any ≥Grade 3 non-infectious pneumonitis or colitis of any duration * Specific liver transaminase elevation as per protocol * Any Grade 3 imAE, including rash, pruritus, or diarrhea, that does not downgrade to Grade 2 or less within 7 days * Grade 3 nausea, vomiting, or diarrhea that does not resolve to Grade 2 or less within 3 days of getting maximal supportive care * ≥Grade 3 neutropenia, without fever or systemic infection, that does not improve by at least one grade within 7 days * Grade 4 thrombocytopenia for more than 7 days or ≥Grade 3 thrombocytopenia along with Grade ≥2 bleeding * Grade 4 Cytokine Release Syndrome (CRS) of any duration or Grade 3 CRS not improving to Grade ≤2 within 72 hours
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed. ORR was defined as the percentage of participants with an objective response \[Best Overall Response of a complete response (CR) or partial response (PR)\] as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed. The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)Population: Response-evaluable set included all dosed participants who had measurable disease at baseline.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Complete Response Rate (CRR)
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in Statistical analysis plan (SAP).
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
0 Percentage of participants
|
33.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)Population: Response-evaluable set included all dosed participants who had measurable disease at baseline.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The ORR was defined as the percentage of participants with an objective response (Best Overall Response of CR or PR) as per modified Lugano criteria (Lugano 2014), as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Objective Response Rate (ORR)
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Percentage of participants
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
0.0 Percentage of participants
Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of ORR.
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
SECONDARY outcome
Timeframe: From first documented response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)Population: Response-evaluable set included all dosed participants who had measurable disease at baseline. Number of participants analyzed were number of participants with objective response.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The DoR was defined as the time from the date of first documented objective response (CR or PR), as assessed by Investigator, using the modified Lugano criteria (Lugano 2014), until the date of first documented disease progression or death (by any cause in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=6 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=3 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=2 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Duration of Response (DoR)
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
—
|
NA Months
Interval 2.7 to
Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of DoR.
|
7.7 Months
Interval 7.1 to
Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of DoR.
|
6.3 Months
Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of DoR.
|
SECONDARY outcome
Timeframe: From first documented complete response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)Population: Response-evaluable set included all dosed participants who had measurable disease at baseline. Number of participants analyzed were number of participants with complete response.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The DoCR was defined as the time from first documented CR, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, until the date of first documented relapse/progression or death due to any cause (in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Outcome measures
| Measure |
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=4 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Duration of Complete Response (DoCR)
|
—
|
—
|
—
|
—
|
—
|
NA Months
Here, 'NA' indicated that data (DOCR) was not calculable due to low number of responders with CR events, as pre-specified in SAP.
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment [C1D1 (each cycle was 28 days)] until date of first documented disease progression or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)Population: Full analysis set included all participants who received any amount of study intervention.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. PFS was defined as the time from first dose until the earlier of the date of first documented disease progression, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, or death (by any cause in the absence of disease progression or subsequent anticancer treatment). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Progression-free Survival (PFS)
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
1.9 Months
Interval 1.4 to
Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.
|
4.8 Months
Interval 2.4 to 11.9
|
5.7 Months
Interval 1.8 to
Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.
|
2.1 Months
Interval 1.6 to 8.1
|
SECONDARY outcome
Timeframe: From start of treatment [C1D1 (each cycle was 28 days)] until date of death due to any cause or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)Population: Full analysis set included all participants who received any amount of study intervention.
The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The OS was defined as the time from the start of treatment until death due to any cause regardless of whether participant withdraws from treatment or receives another anti-lymphoma therapy.
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Overall Survival (OS)
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.
|
NA Months
Interval 1.4 to
Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.
|
NA Months
Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.
|
NA Months
Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.
|
NA Months
Interval 8.4 to
Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.
|
SECONDARY outcome
Timeframe: On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]Population: Immunogenicity analysis set included all participants who received at least 1 dose of study intervention with at least 1 reportable immunogenicity measurement.
The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA prevalence
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
Treatment-induced ADA positive
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
Treatment-boosted ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA incidence
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA positive at baseline and at least one post-baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA positive at baseline and not positive at post-baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA transient positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum
ADA persistently positive
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From C1D1 [before start of infusion (SOI) and at end of infusion (EOI)] to end of study [up to 2 years 5 months (each cycle was 28 days)]Population: Pharmacokinetic (PK) set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
The Cmax of sabestomig in participants with r/r cHL was assessed.
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Maximum Observed Concentration (Cmax)
|
NA microgram (ug)/milliliter (mL)
Interval 0.14 to 0.14
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA microgram (ug)/milliliter (mL)
Interval 1.41 to 1.41
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA microgram (ug)/milliliter (mL)
Interval 5.8 to 5.8
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA microgram (ug)/milliliter (mL)
Interval 15.4 to 15.4
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
52.49 microgram (ug)/milliliter (mL)
Interval 39.6 to 82.9
|
256.00 microgram (ug)/milliliter (mL)
Interval 172.0 to 430.0
|
516.00 microgram (ug)/milliliter (mL)
Interval 364.0 to 1480.0
|
695.10 microgram (ug)/milliliter (mL)
Interval 323.0 to 1400.0
|
SECONDARY outcome
Timeframe: From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]Population: PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
The AUC of sabestomig in participants with r/r cHL was assessed.
Outcome measures
| Measure |
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC)
|
—
|
NA Day*ug/mL
Interval 4.24 to 4.24
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Day*ug/mL
Interval 28.5 to 28.5
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Day*ug/mL
Interval 88.8 to 88.8
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
273.00 Day*ug/mL
Interval 110.0 to 518.0
|
2256.00 Day*ug/mL
Interval 1710.0 to 4780.0
|
4687.00 Day*ug/mL
Interval 2740.0 to 8370.0
|
6883.00 Day*ug/mL
Interval 2560.0 to 8120.0
|
SECONDARY outcome
Timeframe: From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]Population: PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
The CL of sabestomig in participants with r/r cHL was assessed.
Outcome measures
| Measure |
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=4 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=9 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Clearance (CL)
|
—
|
NA Liter (L)/Day
Interval 1.32 to 1.32
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Liter (L)/Day
Interval 0.721 to 0.721
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Liter (L)/Day
Interval 0.816 to 0.816
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
0.4925 Liter (L)/Day
Interval 0.291 to 1.98
|
0.2321 Liter (L)/Day
Interval 0.103 to 0.42
|
0.2211 Liter (L)/Day
Interval 0.101 to 0.318
|
0.2149 Liter (L)/Day
Interval 0.128 to 0.702
|
SECONDARY outcome
Timeframe: From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]Population: PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.
The t½λz of sabestomig in participants with r/r cHL was assessed.
Outcome measures
| Measure |
Cohort A1
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=4 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=9 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=11 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Terminal Elimination Half-life (t½λz)
|
—
|
NA Day
Interval 2.88 to 2.88
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Day
Interval 8.98 to 8.98
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
NA Day
Interval 4.73 to 4.73
Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.
|
9.136 Day
Interval 3.1 to 25.0
|
12.720 Day
Interval 6.68 to 42.8
|
16.440 Day
Interval 11.2 to 22.6
|
12.070 Day
Interval 5.99 to 21.0
|
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The DoR of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The DoCR of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The presence of ADA for sabestomig in treated participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The Cmax of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The AUC of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
The t½λz of sabestomig in participants with r/r cHL was planned to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on PRO-CTCAE was planned to be evaluated. PRO-CTCAE was a PRO measurement system developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE Item Library included 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items were planned to evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE was planned to be assessed by 1 to 3 attributes. Conditional branching logic was planned to be used with electronic data capture, thereby reducing respondent burden. The recall period was planned as the past 7 days and PRO-CTCAE responses were planned to score from 0 to 4 (or 0/1 for absent/present).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on peds-PRO-CTCAE was planned to be evaluated. The pediatric module included 130 items representing 62 symptomatic toxicities and permitted self-reporting by children and adolescents aged 7 to 17 years. In this study, 17 symptomatic toxicities were planned for selection. Thus, the total number of questions that participants would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the participant answered '0' to the initial question for each symptom) to 42 items (assuming that all possible branching questions were triggered for every symptom posed to the participant).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated. For adult participants only, the PGI-TT item was included to assess how a participant perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Participants were planned to be asked to choose the response that best described the level of burden by the side effect of their cancer treatment over the past week. The planned response options were:"not at all", "a little bit", "somewhat", "quite a bit", and "very much".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 years 90 daysPopulation: Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.
Proportion of participants reporting different levels of quality of life/health over time based on the European Organization for Research and Treatment of Cancer Item List (EORTC) ILXX QL2 items was planned to be evaluated. EORTC QLQ-C30 was a 30-item self-administered questionnaire designed for all cancer types. Questions were grouped into 5 multi-item functional scales (physical, role, emotional, cognitive, and social), 3 multi-item symptom scales (fatigue, pain, and nausea/vomiting), 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by participants with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Participants were planned to answer QLQ-C30 questions in reference to how they had been over the past week. Final scores were planned to transform to range from 0 to 100, where higher scores indicated better functioning, better HRQoL, or greater level of symptoms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)Population: Safety set included all participants who received any amount of study intervention. AE of special interest derivations were programmed based on sponsor assessment of AE terms.
The safety and tolerability of sabestomig in participants with r/r cHL were assessed. An AESI was an AE of scientific and medical interest specific to understanding of a study intervention and may have required close monitoring and rapid communication to AstraZeneca by the Investigator. The AESIs for sabestomig include events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy.
Outcome measures
| Measure |
Cohort A1
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 Participants
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Cohort A1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort A4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort A5
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort A6
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Cohort A7
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Cohort A8
Serious events: 2 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort A1
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Exertional rhabdomyolysis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
Other adverse events
| Measure |
Cohort A1
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.
|
Cohort A2
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.
|
Cohort A3
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.
|
Cohort A4
n=1 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.
|
Cohort A5
n=5 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.
|
Cohort A6
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.
|
Cohort A7
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.
|
Cohort A8
n=12 participants at risk
Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
41.7%
5/12 • Number of events 5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 4 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Psychiatric disorders
Suicidal ideation
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
33.3%
4/12 • Number of events 5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Intention tremor
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Eye disorders
Retinopathy
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
25.0%
3/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
25.0%
3/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 4 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
20.0%
1/5 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Chills
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Device related thrombosis
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
25.0%
3/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Pain
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 4 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
16.7%
2/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
100.0%
1/1 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
25.0%
3/12 • Number of events 3 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 2 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/5 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
8.3%
1/12 • Number of events 1 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
0.00%
0/12 • From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)
Safety set included all participants who received any amount of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER