Trial Outcomes & Findings for Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors (NCT NCT04349267)
NCT ID: NCT04349267
Last Updated: 2025-12-17
Results Overview
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)
Results posted on
2025-12-17
Participant Flow
No participants were enrolled in Part 1C.
Participant milestones
| Measure |
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
3
|
5
|
14
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
1
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
3
|
4
|
9
|
12
|
Reasons for withdrawal
| Measure |
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Other reason
|
0
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Disease Progression
|
2
|
0
|
2
|
3
|
3
|
7
|
10
|
|
Overall Study
Participant withdrew consent
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 18.38 • n=6 Participants
|
68.5 years
STANDARD_DEVIATION 2.12 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 13.00 • n=122 Participants
|
70.8 years
STANDARD_DEVIATION 6.91 • n=488 Participants
|
67.4 years
STANDARD_DEVIATION 9.71 • n=182 Participants
|
61.1 years
STANDARD_DEVIATION 8.93 • n=3 Participants
|
64.9 years
STANDARD_DEVIATION 9.55 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=488 Participants
|
6 Participants
n=182 Participants
|
6 Participants
n=3 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=122 Participants
|
4 Participants
n=488 Participants
|
8 Participants
n=182 Participants
|
9 Participants
n=3 Participants
|
28 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=182 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=122 Participants
|
4 Participants
n=488 Participants
|
11 Participants
n=182 Participants
|
10 Participants
n=3 Participants
|
32 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=488 Participants
|
3 Participants
n=182 Participants
|
5 Participants
n=3 Participants
|
12 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
1 Participants
n=182 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=488 Participants
|
0 Participants
n=182 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=488 Participants
|
12 Participants
n=182 Participants
|
12 Participants
n=3 Participants
|
35 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=488 Participants
|
1 Participants
n=182 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Deaths
Deaths
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events and Deaths
Any adverse events
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events and Deaths
Serious Adverse Events
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants With Adverse Events and Deaths
AEs leading to discontinuation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose (Day 1) untill Day 28Population: All treated participants.
A Dose Limiting Toxicity (DLT) is a treatment-related adverse event that is severe enough to prevent an increase in dose or continuation of therapy. DLTs include specific hepatic, hematologic, dermatologic, and other toxicities, such as Grade 4 liver enzyme elevations, Grade 4 cytopenias, persistent Grade 3 rashes, or serious organ toxicities unresponsive to treatment. Certain Grade 3 events (e.g., transient nausea, electrolyte imbalances) are excluded if they resolve quickly or with standard care.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)Population: All treated participants.
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
0.0 percentage of participants
Interval 0.0 to 21.8
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (up to approximately 25 months)Population: All treated participants. Only confirmed responders (CR or PR) were included in the analysis.
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=1 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
—
|
—
|
—
|
—
|
—
|
NA months
Median was not reached due to insufficient number of participants with events" and "95% CI not calculable for a single participant
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: All treated participants.
Progression Free Survival Rates at 6 months is defined as the percentage of participants who achieve PFS at 6 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Rate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Evaluable PK Population
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=11 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=13 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of BMS-986315
|
28.8519 ug/mL
Geometric Coefficient of Variation 40
|
51.9309 ug/mL
Geometric Coefficient of Variation 13
|
168.2658 ug/mL
Geometric Coefficient of Variation 3
|
283.6735 ug/mL
Geometric Coefficient of Variation 66
|
63.1812 ug/mL
Geometric Coefficient of Variation 15
|
160.8894 ug/mL
Geometric Coefficient of Variation 35
|
309.0469 ug/mL
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Evaluable PK Population
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=11 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=13 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of BMS-986315
|
2.1916 hours
Geometric Coefficient of Variation 168
|
2.5151 hours
Geometric Coefficient of Variation 84
|
1.0747 hours
Geometric Coefficient of Variation 10
|
1.8572 hours
Geometric Coefficient of Variation 104
|
1.4213 hours
Geometric Coefficient of Variation 63
|
3.5165 hours
Geometric Coefficient of Variation 249
|
1.9030 hours
Geometric Coefficient of Variation 78
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Evaluable PK Population
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=11 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=13 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of BMS-986315
|
6885.1959 h*ug/mL
Geometric Coefficient of Variation 33
|
12122.1650 h*ug/mL
Geometric Coefficient of Variation 18
|
41381.3449 h*ug/mL
Geometric Coefficient of Variation 12
|
62500.0455 h*ug/mL
Geometric Coefficient of Variation 56
|
12885.5705 h*ug/mL
Geometric Coefficient of Variation 20
|
36893.5416 h*ug/mL
Geometric Coefficient of Variation 32
|
62110.3402 h*ug/mL
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Evaluable PK Population
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=11 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=13 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) of BMS-986315
|
6345.4606 h*ug/mL
Geometric Coefficient of Variation 21
|
13113.1903 h*ug/mL
Geometric Coefficient of Variation 6
|
41381.3449 h*ug/mL
Geometric Coefficient of Variation 12
|
62500.0455 h*ug/mL
Geometric Coefficient of Variation 56
|
12885.5705 h*ug/mL
Geometric Coefficient of Variation 20
|
36893.5416 h*ug/mL
Geometric Coefficient of Variation 32
|
70405.3800 h*ug/mL
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: Evaluable PK Population
Blood samples were collected to assess pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=11 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=13 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Concentration in a Dosing Interval (Ctau) of BMS-986315
|
4.4119 ug/mL
Geometric Coefficient of Variation 20
|
10.7013 ug/mL
Geometric Coefficient of Variation 23
|
33.1011 ug/mL
Geometric Coefficient of Variation 4
|
51.1321 ug/mL
Geometric Coefficient of Variation 66
|
10.5418 ug/mL
Geometric Coefficient of Variation 26
|
28.3387 ug/mL
Geometric Coefficient of Variation 40
|
49.2124 ug/mL
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: All treated participants with baseline and at least one post-baseline evaluable ADA assessment. Participants in Part 1A did not have at least one post-baseline evaluable assessment, hence no participants are included in analysis of Part1A.
An ADA positive participant was defined as participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.
Outcome measures
| Measure |
Part 1A BMS-986315-80 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=12 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=12 Participants
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibody (ADA)
BMS986315 ADA
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibody (ADA)
Nivolumab ADA
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Part 1A BMS-986315-80 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Part 1A BMS-986315-200 mg
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 1A BMS-986315-600 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 1A BMS-986315-1200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
Serious events: 8 serious events
Other events: 14 other events
Deaths: 7 deaths
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
Serious events: 10 serious events
Other events: 15 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Part 1A BMS-986315-80 mg
n=2 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Sudden death
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal stenosis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
Other adverse events
| Measure |
Part 1A BMS-986315-80 mg
n=2 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 80 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-200 mg
n=2 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-600 mg
n=3 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously.
|
Part 1A BMS-986315-1200 mg
n=3 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously.
|
Part 1B BMS-986315-200 mg + Nivolumab 480 mg
n=5 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-600 mg + Nivolumab 480 mg
n=14 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 600 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
Part 1B BMS-986315-1200 mg + Nivolumab 480 mg
n=15 participants at risk
Participants with select advanced tumors like Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC) and Non-small cell lung cancer (NSCLC) received 1200 mg once in 4 weeks (Q4W) intravenously and Nivolumab 480 mg Q4W intravenously.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
3/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Chills
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Cardiac disorders
Atrial flutter
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Eye disorders
Eye disorder
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
42.9%
6/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
5/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
26.7%
4/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
42.9%
6/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
5/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
21.4%
3/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Chest discomfort
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Face oedema
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Fatigue
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
40.0%
2/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
64.3%
9/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
5/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Localised oedema
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Oedema
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
66.7%
2/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
21.4%
3/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
26.7%
4/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
5/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Lip infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Troponin increased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
60.0%
3/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
28.6%
4/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
40.0%
6/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
3/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Aura
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Paraesthesia
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
21.4%
3/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
66.7%
2/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
28.6%
4/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
26.7%
4/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
21.4%
3/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Macule
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
7.1%
1/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
21.4%
3/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
20.0%
1/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
14.3%
2/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
33.3%
1/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
13.3%
2/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
50.0%
1/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/2 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/3 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
0.00%
0/5 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
28.6%
4/14 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
6.7%
1/15 • All-cause mortality was collected from first dose Day 1 and up to approximately 49 months. Serious and Other Adverse events were collected from first dose (Day 1) and 100 days after last dose of study therapy (up to approximately 25 months).
All-cause mortality, serious and other adverse events were collected for all the treated participants.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER