Trial Outcomes & Findings for Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3 (NCT NCT06926673)
NCT ID: NCT06926673
Last Updated: 2025-07-03
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Up to approximately 97 weeks
Results posted on
2025-07-03
Participant Flow
This is a sub-study of the master study NCT03739710.The master protocol included two parts -Part 1 (non-randomized, safety and PK/PD evaluation) and Part 2 (randomized part comparing safety and efficacy to SoC). Criteria on whether to advance a study regimen from Part 1 to Part 2 has been built into the study design. Having completed Part 1 with the allowable number of patients per protocol, the decision was taken to not enroll participants in Part 2. Part 1 was therefore considered completed.
Participant milestones
| Measure |
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
6
|
9
|
9
|
10
|
7
|
|
Overall Study
DLT Evaluable Population
|
0
|
0
|
0
|
4
|
4
|
4
|
7
|
|
Overall Study
COMPLETED
|
9
|
9
|
6
|
6
|
7
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
3
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
3
|
2
|
1
|
0
|
Baseline Characteristics
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 3
Baseline characteristics by cohort
| Measure |
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=7 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
n=11 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to >=85 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
62 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 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
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
Any TEAEs
|
8 Participants
|
—
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Arm 4)
Any SAEs
|
2 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subset of AEs. A TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
Any TEAEs
|
11 Participants
|
—
|
10 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Any TEAEs and SAEs (Arm 5)
Any SAEs
|
3 Participants
|
—
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: DLT-evaluable participants included all participants who took at least 1 dose of study intervention and were followed for the DLT observation period or were withdrawn within the DLT observation period due to meeting the DLT criteria and no resolution/recovery per dose modifications and toxicity management guidelines.
A DLT is an AE meeting criteria such as, hematologic toxicities of Grade (G) 4 neutropenia/anemia/thrombocytopenia (G3 if bleeding). Non-hematological toxicities include persistent G2 eye events, colitis/diarrhea (G2 unresolved to ≤ G1 within 7 days despite immunosuppressive therapy, G3 for ≥ 72 hours, any G4), G3 pneumonitis, rash (unresolved to ≤ G2 within 2 weeks despite treatment), hypersensitivity/IRR, liver events meeting Hy's Law criteria. G3 toxicity unresolved to ≤G1 or baseline within 3 days with supportive care, or any G4 toxicity. Exclusions include G3 events of electrolyte imbalances correctable within 72 hours without effects, nausea/vomiting/fatigue resolving within 7 days, lymphopenia, and enzyme elevations without pancreatitis. Considerations for DLTs include permanent treatment discontinuation, investigator/sponsor judgment-based events including post-observation period toxicities.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=4 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=4 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=4 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=7 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (Arm 4 and Arm 5)
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population.
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Missed Doses
|
2 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Dose Delays
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 4)
Infusion Interruptions
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population.
Number of participants with dose modifications (missed doses, dose delays and infusion interruptions) is summarized.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Missed Doses
|
5 Participants
|
—
|
6 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Dose Delays
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants Requiring Dose Modifications (Arm 5)
Infusion Interruptions
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Baseline, Grade 0
|
3 Participants
|
—
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Baseline, Grade 1
|
6 Participants
|
—
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 4, Grade 0
|
3 Participants
|
—
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 4, Grade 1
|
4 Participants
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 4, Grade 2
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 7, Grade 0
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 7, Grade 1
|
5 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 10, Grade 0
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 10, Grade 1
|
3 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 13, Grade 0
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 13, Grade 1
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 16, Grade 0
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 16, Grade 1
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 19, Grade 0
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 19, Grade 1
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 22, Grade 0
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 22, Grade 1
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 25, Grade 0
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 25, Grade 1
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 28, Grade 0
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 28 Grade 1
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 31, Grade 0
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 34, Grade 0
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 37, Grade 0
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 40, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 43, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 46, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 49, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 52, Grade 1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 55, Grade 1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 58, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 61, Grade 0
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 64, Grade 1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 67, Grade 1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Week 70, Grade 1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Treatment Discontinuation (up to 97 weeks), Grade 0
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Treatment Discontinuation (up to 97 weeks), Grade 1
|
4 Participants
|
—
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Treatment Discontinuation (up to 97 weeks), Grade 2
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 4)
Treatment Discontinuation (up to 97 weeks), Grade 3
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Performance Status was assessed using the ECOG scale (Grades 0-5), where 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Baseline, Grade 0
|
7 Participants
|
—
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Baseline, Grade 1
|
4 Participants
|
—
|
6 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 4, Grade 0
|
5 Participants
|
—
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 4, Grade 1
|
6 Participants
|
—
|
4 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 4, Grade 2
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 7, Grade 0
|
3 Participants
|
—
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 7, Grade 1
|
4 Participants
|
—
|
3 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 7, Grade 2
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 10, Grade 0
|
3 Participants
|
—
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 10, Grade 1
|
3 Participants
|
—
|
5 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 10, Grade 2
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 13, Grade 0
|
2 Participants
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 13, Grade 1
|
2 Participants
|
—
|
3 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 16, Grade 0
|
2 Participants
|
—
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 16, Grade 1
|
2 Participants
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 19, Grade 0
|
2 Participants
|
—
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 19, Grade 1
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 22, Grade 0
|
2 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 22, Grade 1
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 25, Grade 0
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 25, Grade 1
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 28, Grade 0
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 28, Grade 1
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 31, Grade 0
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 34, Grade 0
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 37, Grade 0
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 37, Grade 1
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 40, Grade 0
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 40, Grade 1
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 43, Grade 0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 43, Grade 1
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 46, Grade 0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 46, Grade 1
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 49, Grade 0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 49, Grade 2
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 52, Grade 0
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 55, Grade 0
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Week 58, Grade 0
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Treatment Discontinuation (up to 107 weeks), Grade 0
|
4 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Treatment Discontinuation (up to 107 weeks), Grade 1
|
4 Participants
|
—
|
5 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Treatment Discontinuation (up to 107 weeks), Grade 2
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (Arm 5)
Treatment Discontinuation (up to 107 weeks), Grade 3
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Diastolic Blood Pressure, Any Grade Increase
|
2 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Diastolic Blood Pressure, Increase to Grade 2
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Diastolic Blood Pressure, Increase to Grade 3
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Systolic Blood Pressure, Any Grade Increase
|
3 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Systolic Blood Pressure, Increase to Grade 2
|
2 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Systolic Blood Pressure, Increase to Grade 3
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Heart Rate, Decrease to <60 bpm
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Heart Rate, Change to Normal or No Change
|
6 Participants
|
—
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Heart Rate, Increase to >100 bpm
|
2 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Temperature, Decrease to <=35 °C
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Temperature, Change to Normal or No Change
|
6 Participants
|
—
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 4)
Temperature, Increase to >=38 °C
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Vital signs including systolic blood pressure (SBP), diastolic BP (DBP), pulse rate (PR) and body temperature (BT) were measured for the participants. DBP: Grade 0 (\<80 millimeters of mercury \[mmHg\]), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg); SBP: Grade 0 (\<120 mmHg), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg); PR categories include: 'Decrease to \< 60 beats per minutes \[bpm\]', 'Change to Normal' or 'No Change', and 'Increase to \>100 bpm'; BT categories include 'Decrease to \<=35 degrees Celsius °C', 'Change to Normal' or 'No Change', and 'Increase to \>=38 °C'. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=9 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Diastolic Blood Pressure, Any Grade Increase
|
4 Participants
|
—
|
5 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Diastolic Blood Pressure, Increase to Grade 2
|
1 Participants
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Diastolic Blood Pressure, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Systolic Blood Pressure, Any Grade Increase
|
5 Participants
|
—
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Systolic Blood Pressure, Increase to Grade 2
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Systolic Blood Pressure, Increase to Grade 3
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Heart Rate, Decrease to <60 bpm
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Heart Rate, Change to Normal or No Change
|
9 Participants
|
—
|
7 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Heart Rate, Increase to >100 bpm
|
2 Participants
|
—
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Temperature, Decrease to <=35 C
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Temperature, Change to Normal or No Change
|
11 Participants
|
—
|
10 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Increase From Baseline in Vital Signs (Arm 5)
Temperature, Increase to >=38 C
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Intent To Treat (ITT) population included all participants who were randomized to treatment regardless of whether the participants actually received study treatment.
Number of participants who received Concomitant medications is summarized.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Who Received Concomitant Medications (Arm 4)
|
9 Participants
|
—
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Intent To Treat (ITT) population
Number of participants who received Concomitant medications is summarized.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants Who Received Concomitant Medications (Arm 5)
|
11 Participants
|
—
|
10 Participants
|
7 Participants
|
10 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Baseline · Normal
|
4 Participants
|
—
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Baseline · Abnormal - NCS
|
3 Participants
|
—
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Baseline · Abnormal - CS
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Worst-case post baseline · Normal
|
3 Participants
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Worst-case post baseline · Abnormal - NCS
|
2 Participants
|
—
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline Electrocardiogram (ECG) Findings (Arm 4)
Worst-case post baseline · Abnormal - CS
|
3 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Number of participants with worst-case post baseline (WCPB) from baseline ECG findings is summarized as clinically significant. Data is summarized as Normal, Abnormal - Not Clinically Significant (NCS) and Abnormal - Clinically Significant (CS). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Baseline · Normal
|
5 Participants
|
—
|
5 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Baseline · Abnormal - NCS
|
5 Participants
|
—
|
4 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Baseline · Abnormal - CS
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Worst-case post baseline · Normal
|
4 Participants
|
—
|
0 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Worst-case post baseline · Abnormal - NCS
|
4 Participants
|
—
|
7 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline ECG Findings (Arm 5)
Worst-case post baseline · Abnormal - CS
|
3 Participants
|
—
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
Baseline, Grade 0
|
8 Participants
|
—
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
Baseline, Grade 1
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
Baseline, Grade 2
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
Baseline, Grade 3
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
WCPB, No Grade Increase
|
7 Participants
|
—
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 4)
WCPB, Increase to Grade 1
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
The QTcF values based on Fridericia formula were rounded to the integer and the values are categorized into the following ranges, inclusively: Grade 0 (\<450 millisecond (msec)), Grade 1 (≥450-≤480 msec), Grade 2 (≥481-≤500 msec), and Grade 3 (≥501 msec). Missing baseline grades were assumed to be Grade 0. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
Baseline, Grade 0
|
10 Participants
|
—
|
10 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
Baseline, Grade 1
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
Baseline, Grade 2
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
Baseline, Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
WCPB, No Grade Increase
|
11 Participants
|
—
|
10 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
WCPB, Increase to Grade 2
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in QTcF Interval (Arm 5)
WCPB, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=1 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
No change or any increase
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
Any Decrease
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
>=10% Decrease and >= LLN
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
>=10% Decrease and < LLN
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
>=20% Decrease and >= LLN
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 4)
>=20% Decrease and < LLN
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Number of participants with worst case post-baseline in LVEF from baseline is summarized as 'any decrease (\>0%-\<10% Decrease, 10%-19% Decrease, \>=20% Decrease)', '\>=10% Decrease and \>= Lower limit of normal (LLN)', '\>=10% Decrease and \< LLN', '\>=20% Decrease and \>= LLN' and '\>=20% Decrease and \< LLN' . An increase is defined as an increase in grade relative to Baseline grade. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=2 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=2 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=1 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
No change or any increase
|
0 Participants
|
—
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
Any Decrease
|
2 Participants
|
—
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
>=10% Decrease and >= LLN
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
>=10% Decrease and < LLN
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
>=20% Decrease and >= LLN
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-case Post Baseline Relative to Baseline in Left Ventricular Ejection Fraction (LVEF) (Arm 5)
>=20% Decrease and < LLN
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Eosinophils, Any Grade Increase
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Eosinophils, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Eosinophils, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count decreased, Any Grade Increase
|
6 Participants
|
—
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count decreased, Increase to Grade 3
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count increased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Platelet count decreased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Platelet count decreased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Platelet count decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
White blood cell decreased, Any Grade Increase
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
White blood cell decreased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Anemia, Any Grade Increase
|
1 Participants
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Anemia, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Anemia, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Hemoglobin increased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Neutrophil count decreased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Neutrophil count decreased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Neutrophil count decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Eosinophils, Any Grade Increase
|
3 Participants
|
—
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Eosinophils, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Eosinophils, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count decreased, Any Grade Increase
|
8 Participants
|
—
|
8 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count decreased, Increase to Grade 3
|
4 Participants
|
—
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count decreased, Increase to Grade 4
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count increased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Platelet count decreased, Any Grade Increase
|
2 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Platelet count decreased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Platelet count decreased, Increase to Grade 4
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
White blood cell decreased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
White blood cell decreased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Anemia, Any Grade Increase
|
4 Participants
|
—
|
6 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Anemia, Increase to Grade 3
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Anemia, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Hemoglobin increased, Any Grade Increase
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Neutrophil count decreased, Any Grade Increase
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Neutrophil count decreased, Increase to Grade 3
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Neutrophil count decreased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Activated Partial Thromboplastin Time (aPTT), Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
aPTT, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
aPTT, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Glucose, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Glucose, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Glucose, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
International normalized ratio (INR) increased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
INR increased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
INR increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Alkaline phosphatase (AP), Any Grade Increase
|
1 Participants
|
—
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
AP, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
AP, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Alanine aminotransferase (ALT), Any Grade Increase
|
0 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
ALT, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
ALT, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Aspartate aminotransferase (AST), Any Grade Increase
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
AST, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
AST, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Bilirubin, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Bilirubin, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Bilirubin, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Creatinine, Any Grade Increase
|
3 Participants
|
—
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Creatinine, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Creatinine, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Potassium, Any Grade Increase
|
1 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Potassium, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Potassium, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lactate Dehydrogenase, Any Grade Increase
|
3 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lactate Dehydrogenase, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Lactate Dehydrogenase, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Sodium, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Sodium, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Sodium, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Albumin, Any Grade Increase
|
4 Participants
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Albumin, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 4)
Albumin, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade is defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and 4 is summarized. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Albumin, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Albumin, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
aPTT, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
aPTT, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
aPTT, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Glucose, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Glucose, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Glucose, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
INR increased, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
INR increased, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
INR increased, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AP, Any Grade Increase
|
1 Participants
|
—
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AP, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AP, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
ALT, Any Grade Increase
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
ALT, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
ALT, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AST, Any Grade Increase
|
3 Participants
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AST, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
AST, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Bilirubin, Any Grade Increase
|
2 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Bilirubin, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Bilirubin, Increase to Grade 4
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Creatinine, Any Grade Increase
|
3 Participants
|
—
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Creatinine, Increase to Grade 3
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Creatinine, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Potassium, Any Grade Increase
|
2 Participants
|
—
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Potassium, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Potassium, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lactate Dehydrogenase, Any Grade Increase
|
4 Participants
|
—
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lactate Dehydrogenase, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Lactate Dehydrogenase, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Sodium, Any Grade Increase
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Sodium, Increase to Grade 3
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Sodium, Increase to Grade 4
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline (Arm 5)
Albumin, Any Grade Increase
|
4 Participants
|
—
|
6 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%.When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an "Unknown" or "Data missing" category.
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Normal, WCPB Normal
|
2 Participants
|
—
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Normal, WCPB Low
|
5 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Normal, WCPB Normal
|
5 Participants
|
—
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Normal, WCPB Low
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B High, WCPB High
|
1 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Normal, WCPB High
|
1 Participants
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Calcium, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Normal, WCPB High
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Normal, WCPB Normal
|
5 Participants
|
—
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Normal, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Lipase, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Normal, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Normal, WCPB Normal
|
6 Participants
|
—
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Normal, WCPB Low
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Amylase, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Normal, WCPB High
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Normal, WCPB Normal
|
5 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Normal, WCPB Low
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Low, WCPB Normal
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Urea, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Free Triiodothyronine (T3), B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Normal, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Normal, WCPB Normal
|
4 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Normal, WCPB Low
|
1 Participants
|
—
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T3, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Free Thyroxine (T4), B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Normal, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Normal, WCPB Normal
|
5 Participants
|
—
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Normal, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Low, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
T4, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Normal, WCPB High
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Normal, WCPB Normal
|
3 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Normal, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Troponin I, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B High, WCPB High
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Normal, WCPB High
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Low, WCPB Normal
|
0 Participants
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 4)
Thyrotropin, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed. Participants were counted twice if the participants have values that changed 'To Low' and 'To High', so the percentages may not add to 100%. When lab values were not analyzed for some participants, the Number of Participants Analyzed will be less than the total across categories, allowing for a direct comparison without adding an "Unknown" or "Data missing" category.
Blood samples were collected for analysis of clinical chemistry. The summaries of worst-case post baseline (WCPB) from baseline (B) with respect to normal range was analyzed. Data is presented as "XXX B YYY, WCPB YYY", where XXX denotes lab parameter and YYY is high/normal/low. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Normal, WCPB High
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Normal, WCPB Normal
|
7 Participants
|
—
|
9 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Normal, WCPB Low
|
3 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Low, WCPB Normal
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Calcium, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B High, WCPB High
|
0 Participants
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Normal, WCPB High
|
2 Participants
|
—
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Normal, WCPB Normal
|
6 Participants
|
—
|
5 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Normal, WCPB Low
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Lipase, B Low, WCPB Low
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B High, WCPB High
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Normal, WCPB High
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Normal, WCPB Normal
|
7 Participants
|
—
|
6 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Normal, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Amylase, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B High, WCPB High
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Normal, WCPB High
|
2 Participants
|
—
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Normal, WCPB Normal
|
3 Participants
|
—
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Normal, WCPB Low
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Urea, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Free Triiodothyronine (T3), B High, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Normal, WCPB High
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Normal, WCPB Normal
|
6 Participants
|
—
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Normal, WCPB Low
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T3, B Low, WCPB Low
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Free Thyroxine (T4), B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Normal, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Normal, WCPB Normal
|
7 Participants
|
—
|
7 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Normal, WCPB Low
|
1 Participants
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
T4, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B High, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Normal, WCPB High
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Normal, WCPB Normal
|
5 Participants
|
—
|
2 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Normal, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Low, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Troponin I, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B High, WCPB High
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B High, WCPB Normal
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B High, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Normal, WCPB High
|
1 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Normal, WCPB Normal
|
5 Participants
|
—
|
5 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Normal, WCPB Low
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Low, WCPB High
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Low, WCPB Normal
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Change Post-baseline in Clinical Chemistry Parameters (Arm 5)
Thyrotropin, B Low, WCPB Low
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=5 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Occult Blood, No Change/Decreased
|
7 Participants
|
—
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Occult Blood, Any Increase
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Occult Blood, Unknown
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Protein, No Change/Decreased
|
7 Participants
|
—
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Protein, Any Increase
|
1 Participants
|
—
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 4)
Protein, Unknown
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Safety Population. Only those participants with data available at specified parameters have been analyzed.
Urinalysis was performed. Participants with missing value at baseline are assumed to be negative at baseline. All increases are from baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=6 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=8 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Occult Blood, No Change/Decreased
|
6 Participants
|
—
|
4 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Occult Blood, Any Increase
|
5 Participants
|
—
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Occult Blood, Unknown
|
0 Participants
|
—
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Protein, No Change/Decreased
|
5 Participants
|
—
|
3 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Protein, Any Increase
|
6 Participants
|
—
|
5 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline (Arm 5)
Protein, Unknown
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
OS is defined as the time from date of randomization to the date of death, irrespective of the cause of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Intent To Treat (ITT) population.
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Objective Response Rate (ORR) (Arm 4)
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
—
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Intent To Treat (ITT) population
ORR is defined as the percentage of participants with a best overall confirmed CR or PR at any time as per disease-specific criteria per RECIST version 1.1. CR is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Objective Response Rate (ORR) (Arm 5)
|
9 Percentage of Participants
Interval 0.2 to 41.3
|
—
|
0 Percentage of Participants
Interval 0.0 to 30.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 30.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 97 weeksPopulation: Intent To Treat (ITT) population
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Disease Control Rate (DCR) (Arm 4)
|
11 Percentage of Participants
Interval 0.3 to 48.2
|
—
|
17 Percentage of Participants
Interval 0.4 to 64.1
|
22 Percentage of Participants
Interval 2.8 to 60.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: Intent To Treat (ITT) population
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Disease Control Rate (DCR) (Arm 5)
|
27 Percentage of Participants
Interval 6.0 to 61.0
|
—
|
40 Percentage of Participants
Interval 12.2 to 73.8
|
14 Percentage of Participants
Interval 0.4 to 57.9
|
0 Percentage of Participants
Interval 0.0 to 30.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 21 days (Cycle 1)Population: Pharmacokinetic (PK) population included all participants from the ITT Population from whom a blood sample is obtained and analyzed for PK concentration. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=8 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Cmax
|
271.835 Microgram/ millilitre (ug/mL)
Standard Deviation 77.5244
|
—
|
88.470 Microgram/ millilitre (ug/mL)
Standard Deviation 92.2653
|
118.762 Microgram/ millilitre (ug/mL)
Standard Deviation 46.4217
|
—
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 4)
Cmin
|
44.350 Microgram/ millilitre (ug/mL)
Standard Deviation 24.4184
|
—
|
9.412 Microgram/ millilitre (ug/mL)
Standard Deviation 5.6264
|
22.091 Microgram/ millilitre (ug/mL)
Standard Deviation 8.4224
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 21 days (Cycle 1)Population: Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Blood samples were collected for pharmacokinetic analysis of Belrestotug.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=10 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Cmax
|
153.377 ug/mL
Standard Deviation 33.5154
|
—
|
126.386 ug/mL
Standard Deviation 21.8676
|
137.837 ug/mL
Standard Deviation 34.5390
|
22.967 ug/mL
Standard Deviation 7.0701
|
—
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Belrestotug (Arm 5)
Cmin
|
153.069 ug/mL
Standard Deviation 54.3450
|
—
|
19.408 ug/mL
Standard Deviation 6.4103
|
20.752 ug/mL
Standard Deviation 11.5836
|
21.693 ug/mL
Standard Deviation 9.2699
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 21 days (Cycle 1)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Cmax
|
97.433 ug/mL
Standard Deviation 34.2035
|
—
|
119.400 ug/mL
Standard Deviation 60.9173
|
124.278 ug/mL
Standard Deviation 40.6026
|
—
|
—
|
—
|
|
Part 1: Cmax and Cmin of Dostarlimab (Arm 4)
Cmin
|
22.935 ug/mL
Standard Deviation 7.9792
|
—
|
33.900 ug/mL
Standard Deviation 15.3454
|
34.071 ug/mL
Standard Deviation 8.5638
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 21 days (Cycle 1)Population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Blood samples were collected for pharmacokinetic analysis of Dostarlimab.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=11 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=10 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=10 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Cmax
|
68.751 ug/mL
Standard Deviation 43.8090
|
—
|
108.920 ug/mL
Standard Deviation 32.2323
|
126.857 ug/mL
Standard Deviation 51.0830
|
109.330 ug/mL
Standard Deviation 121.1920
|
—
|
—
|
|
Part 1: Cmax and Cmin of Dostarlimab (Arm 5)
Cmin
|
34.218 ug/mL
Standard Deviation 12.3900
|
—
|
29.290 ug/mL
Standard Deviation 12.4519
|
34.550 ug/mL
Standard Deviation 13.2960
|
39.013 ug/mL
Standard Deviation 26.8319
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 21 days (Cycle 1)Population: Pharmacokinetic (PK) population. PK parameters were only calculated for treatment cycles in which sufficient data were available to do so.
Blood samples were collected for pharmacokinetic analysis of Nelistotug.
Outcome measures
| Measure |
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)]
n=10 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=9 Participants
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=7 Participants
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=8 Participants
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received Nelistotug HD.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Cmax
|
75.580 ug/mL
Standard Deviation 12.4318
|
—
|
299.889 ug/mL
Standard Deviation 313.2561
|
479.714 ug/mL
Standard Deviation 219.7148
|
554.750 ug/mL
Standard Deviation 140.7792
|
—
|
—
|
|
Part 1: Cmax and Cmin of Nelistotug (Arm 5)
Cmin
|
15.070 ug/mL
Standard Deviation 2.9601
|
—
|
43.689 ug/mL
Standard Deviation 13.7240
|
88.243 ug/mL
Standard Deviation 34.7201
|
123.975 ug/mL
Standard Deviation 66.4588
|
—
|
—
|
SECONDARY outcome
Timeframe: At 12 and 18 monthsPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Survival rate was planned to be anaysed at 12 and 18 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
CR, PR, SD and PD was planned to be evaluated as per RECIST version 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
PFS is defined as time from the date of randomization to the date of disease progression as per RECIST v1.1. or death whichever occurs earlier. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
ORR is defined as the percentage of participants with a best overall confirmed Complete response (CR) or Partial response (PR) at any time as per disease-specific criteria per RECIST version 1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
DOR is defined as the time for first documented evidence of CR or PR until disease progression or death, per RECIST 1.1 criteria. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
DCR is defined as the percentage of participants with a confirmed CR + PR at any time, plus SD =\>12 weeks as per RECIST v1.1. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST is used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed and NE: not evaluable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
iPFS is defined as time from the date of randomization to the date of disease progression or death, whichever occurs earlier, per iRECIST criteria. Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
iORR is defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
iDOR is defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. iCR is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement. AESI are considered to be Infusion Related Reactions (IRRs) and those of potential immunologic etiology. AEs were planned to be coded using the MedDRA coding system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Clinically significant changes in vital signs were planned to be assessed. Blood samples were planned to be collected for the analysis of laboratory parameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Blood samples were planned to be collected to assess the pharmacokinetics of Dostarlimab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Blood samples were planned to be collected to assess the pharmacokinetics of Belrestotug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 107 weeksPopulation: No participants were enrolled in Part 2 of the study. Hence, data was not collected.
Serum samples were planned to be collected for the analysis of the presence of ADAs using validated immunoassays.
Outcome measures
Outcome data not reported
Adverse Events
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
Serious events: 0 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
Serious events: 3 serious events
Other events: 9 other events
Deaths: 5 deaths
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)])
Serious events: 2 serious events
Other events: 8 other events
Deaths: 7 deaths
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
Serious events: 3 serious events
Other events: 10 other events
Deaths: 7 deaths
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
Serious events: 3 serious events
Other events: 11 other events
Deaths: 7 deaths
Arm 5 Randomized Part: Belrestotug(MD) + Dostarlimab + Nelistotug (HD)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 participants at risk
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)])
n=9 participants at risk
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
n=10 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=7 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
n=11 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
Arm 5 Randomized Part: Belrestotug(MD) + Dostarlimab + Nelistotug (HD)
n=10 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received various dose levels.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
Other adverse events
| Measure |
Arm 4: Dostarlimab + Belrestotug [Low Dose (LD)]
n=6 participants at risk
Participants with Non-Small Cell Lung Cancer (NSCLC) were administered with 500 milligrams (mg) of Dostarlimab as IV infusion once every 3 weeks (Q3W) in combination with Belrestotug LD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [Medium Dose (MD)]
n=9 participants at risk
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion Q3W in combination with Belrestotug MD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 4: Dostarlimab + Belrestotug [High Dose (HD)])
n=9 participants at risk
Participants with NSCLC were administered with 500 mg of Dostarlimab as IV infusion once Q3W in combination with Belrestotug HD as IV infusion Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug MD
n=10 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug MD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Safety Part: Belrestotug MD + Dostarlimab + Nelistotug HD
n=7 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. Participants in this safety part were evaluated to determine the maximum tolerable dose tested.
|
Arm 5 Randomized Part: Belrestotug MD + Dostarlimab + Nelistotug LD
n=11 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug LD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for pharmacokinetics/pharmacodynamics (PK/PD) and received Nelistotug LD
|
Arm 5 Randomized Part: Belrestotug(MD) + Dostarlimab + Nelistotug (HD)
n=10 participants at risk
Participants with NSCLC received 500 mg Dostarlimab followed by Belrestotug MD and Nelistotug HD. Treatment were given via IV infusion from day 1 to Q3W for maximum duration of approximately 2 years or up to 35 treatment visits whichever comes first, or until disease progression, death, unacceptable toxicity, or other protocol-defined criteria are met. In this randomization part, participants were assessed for PK/PD and received various dose levels.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Blood and lymphatic system disorders
Subcapsular splenic haematoma
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Asthenia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Chest pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
30.0%
3/10 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Chills
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Discomfort
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Face oedema
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
27.3%
3/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Oedema
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
33.3%
3/9 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
General disorders
Xerosis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
33.3%
3/9 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
42.9%
3/7 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
45.5%
5/11 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Blood sodium increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Troponin T increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Troponin increased
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
44.4%
4/9 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Capillaritis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 4 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
33.3%
3/9 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
22.2%
2/9 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
18.2%
2/11 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
30.0%
3/10 • Number of events 5 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
16.7%
1/6 • Number of events 3 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
20.0%
2/10 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
10.0%
1/10 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/11 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
11.1%
1/9 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/9 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/7 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
9.1%
1/11 • Number of events 1 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
0.00%
0/10 • All cause mortality, non-SAEs and SAEs were collected up to approximately 97 weeks for arm 4 and up to approximately 107 weeks for arm 5.
Safety Population included all participants who received at least 1 dose of standard of care (SoC) or experimental regimen based on actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER