Trial Outcomes & Findings for A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma (NCT NCT05909904)
NCT ID: NCT05909904
Last Updated: 2026-07-14
Results Overview
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Up to 21.2 months
Results posted on
2026-07-14
Participant Flow
Participants were enrolled at 57 centers in 13 countries globally. The main part of the study completed on 17 June 2025. At that time, participants who continued to receive clinical benefit were offered continued access to study treatment in the Extended Access Period. Results are reported up to the data cut-off date of 17 June 2025.
Eligible participants were randomized in a 1:1 ratio into the four treatment groups. Randomization was stratified based on programmed cell death protein ligand-1 (PD-L1) expression.
Participant milestones
| Measure |
Tislelizumab
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
Received Treatment
|
40
|
39
|
40
|
40
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
40
|
40
|
Reasons for withdrawal
| Measure |
Tislelizumab
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Study
Death
|
19
|
16
|
20
|
19
|
|
Overall Study
Main Study Closed by Sponsor
|
3
|
7
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
1
|
|
Overall Study
Participant not Eligible
|
0
|
1
|
1
|
0
|
|
Overall Study
Remaining on Study
|
16
|
11
|
13
|
13
|
Baseline Characteristics
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=27 Participants
|
24 Participants
n=9 Participants
|
18 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
85 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=27 Participants
|
16 Participants
n=9 Participants
|
22 Participants
n=267 Participants
|
22 Participants
n=265 Participants
|
75 Participants
n=568 Participants
|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 10.42 • n=27 Participants
|
61.5 years
STANDARD_DEVIATION 10.49 • n=9 Participants
|
63.2 years
STANDARD_DEVIATION 12.31 • n=267 Participants
|
63.8 years
STANDARD_DEVIATION 11.20 • n=265 Participants
|
62.8 years
STANDARD_DEVIATION 11.06 • n=568 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=27 Participants
|
7 Participants
n=9 Participants
|
6 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
25 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=27 Participants
|
33 Participants
n=9 Participants
|
34 Participants
n=267 Participants
|
33 Participants
n=265 Participants
|
135 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
31 Participants
n=27 Participants
|
23 Participants
n=9 Participants
|
28 Participants
n=267 Participants
|
31 Participants
n=265 Participants
|
113 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
9 Participants
n=27 Participants
|
16 Participants
n=9 Participants
|
12 Participants
n=267 Participants
|
8 Participants
n=265 Participants
|
45 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=27 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
39 Participants
n=27 Participants
|
36 Participants
n=9 Participants
|
39 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
151 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=27 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
0 Participants
n=27 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
1 Participants
n=27 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=27 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Region of Enrollment
China
|
12 participants
n=27 Participants
|
8 participants
n=9 Participants
|
14 participants
n=267 Participants
|
12 participants
n=265 Participants
|
46 participants
n=568 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=27 Participants
|
5 participants
n=9 Participants
|
6 participants
n=267 Participants
|
5 participants
n=265 Participants
|
26 participants
n=568 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=27 Participants
|
4 participants
n=9 Participants
|
6 participants
n=267 Participants
|
7 participants
n=265 Participants
|
24 participants
n=568 Participants
|
|
Region of Enrollment
Thailand
|
2 participants
n=27 Participants
|
6 participants
n=9 Participants
|
2 participants
n=267 Participants
|
5 participants
n=265 Participants
|
15 participants
n=568 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=27 Participants
|
1 participants
n=9 Participants
|
1 participants
n=267 Participants
|
4 participants
n=265 Participants
|
9 participants
n=568 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=27 Participants
|
3 participants
n=9 Participants
|
3 participants
n=267 Participants
|
1 participants
n=265 Participants
|
8 participants
n=568 Participants
|
|
Region of Enrollment
Georgia
|
4 participants
n=27 Participants
|
2 participants
n=9 Participants
|
2 participants
n=267 Participants
|
0 participants
n=265 Participants
|
8 participants
n=568 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=27 Participants
|
3 participants
n=9 Participants
|
2 participants
n=267 Participants
|
2 participants
n=265 Participants
|
7 participants
n=568 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=27 Participants
|
3 participants
n=9 Participants
|
3 participants
n=267 Participants
|
1 participants
n=265 Participants
|
7 participants
n=568 Participants
|
|
Region of Enrollment
France
|
0 participants
n=27 Participants
|
2 participants
n=9 Participants
|
1 participants
n=267 Participants
|
2 participants
n=265 Participants
|
5 participants
n=568 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=27 Participants
|
2 participants
n=9 Participants
|
0 participants
n=267 Participants
|
0 participants
n=265 Participants
|
3 participants
n=568 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=27 Participants
|
0 participants
n=9 Participants
|
0 participants
n=267 Participants
|
1 participants
n=265 Participants
|
1 participants
n=568 Participants
|
|
Region of Enrollment
Turkey (Türkiye)
|
0 participants
n=27 Participants
|
1 participants
n=9 Participants
|
0 participants
n=267 Participants
|
0 participants
n=265 Participants
|
1 participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Up to 21.2 monthsPopulation: Intent-to-Treat (ITT) Analysis Set: all randomized participants.
ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
27.5 Percentage of Participants
Interval 14.6 to 43.9
|
27.5 Percentage of Participants
Interval 14.6 to 43.9
|
25.0 Percentage of Participants
Interval 12.7 to 41.2
|
27.5 Percentage of Participants
Interval 14.6 to 43.9
|
SECONDARY outcome
Timeframe: Up to 21.2 monthsPopulation: ITT Analysis Set: all randomized participants.
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) assessed by the investigators per RECIST v1.1 or death, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
2.6 months
Interval 1.4 to 6.4
|
5.4 months
Interval 2.8 to 6.9
|
3.4 months
Interval 1.6 to 5.8
|
4.1 months
Interval 3.0 to 5.6
|
SECONDARY outcome
Timeframe: Up to 21.2 monthsPopulation: ITT Analysis Set, Responders: all randomized participants who had a confirmed CR or PR.
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurred first.
Outcome measures
| Measure |
Tislelizumab
n=11 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=11 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=10 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=11 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
8.2 months
Interval 3.9 to
Upper Confidence Interval could not be estimated due to an insufficient number of events.
|
NA months
Interval 2.6 to
Median and Upper Confidence Interval could not be estimated due to an insufficient number of events.
|
NA months
Interval 8.4 to
Median and Upper Confidence Interval could not be estimated due to an insufficient number of events.
|
NA months
Interval 3.4 to
Median and Upper Confidence Interval could not be estimated due to an insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to 21.2 monthsPopulation: ITT Analysis Set: all randomized participants.
CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or durable stable disease (SD) (SD duration ≥ 24 weeks). SD is defined as neither sufficient decrease in size of target lesions to qualify for PR nor sufficient increase to qualify for PD, no progressive disease in nontarget lesions, and no new lesions.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
32.5 Percentage of Participants
Interval 18.6 to 49.1
|
37.5 Percentage of Participants
Interval 22.7 to 54.2
|
35.0 Percentage of Participants
Interval 20.6 to 51.7
|
37.5 Percentage of Participants
Interval 22.7 to 54.2
|
SECONDARY outcome
Timeframe: Up to 21.2 monthsPopulation: ITT Analysis Set: all randomized participants.
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
55.0 Percentage of Participants
Interval 38.5 to 70.7
|
67.5 Percentage of Participants
Interval 50.9 to 81.4
|
62.5 Percentage of Participants
Interval 45.8 to 77.3
|
65.0 Percentage of Participants
Interval 48.3 to 79.4
|
SECONDARY outcome
Timeframe: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.Population: Safety Analysis Set: all participants who received at least one dose of study drug.
Number of participants with adverse events (AEs), including laboratory values, vital signs, physical examinations, and electrocardiogram findings. AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being least severe and Grade 5 being most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was considered a significant medical AE by the investigator based on medical judgement.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=39 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Participants with any Treatment-Emergent Adverse Event (TEAE)
|
37 Participants
|
34 Participants
|
39 Participants
|
40 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Participants with a TEAE of Grade 3 or Higher
|
21 Participants
|
15 Participants
|
14 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Participants with a Serious TEAE
|
17 Participants
|
14 Participants
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 21.2 monthsPopulation: ITT Analysis Set: all randomized participants.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Outcome measures
| Measure |
Tislelizumab
n=40 Participants
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 Participants
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 6.6 to
The median and upper confidence interval could not be estimated due to an insufficient number of events.
|
18.3 Months
Interval 10.5 to
The upper confidence interval could not be estimated due to an insufficient number of events.
|
14.9 Months
Interval 9.9 to
The upper confidence interval could not be estimated due to an insufficient number of events.
|
14.4 Months
Interval 7.7 to
The upper confidence interval could not be estimated due to an insufficient number of events.
|
Adverse Events
Tislelizumab
Serious events: 17 serious events
Other events: 36 other events
Deaths: 19 deaths
Tislelizumab + Surzebiclimab
Serious events: 14 serious events
Other events: 32 other events
Deaths: 16 deaths
Tislelizumab + Alcestobart
Serious events: 11 serious events
Other events: 37 other events
Deaths: 20 deaths
Tislelizumab + Surzebiclimab + Alcestobart
Serious events: 16 serious events
Other events: 39 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Tislelizumab
n=40 participants at risk
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=39 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocarditis
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Malignant dysphagia
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
7.5%
3/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
2.5%
1/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
2.5%
1/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
7.5%
3/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 9 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 9 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Tislelizumab
n=40 participants at risk
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab
n=39 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Alcestobart
n=40 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
Tislelizumab + Surzebiclimab + Alcestobart
n=40 participants at risk
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle. Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
8/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
20.5%
8/39 • Number of events 19 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 12 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
37.5%
15/40 • Number of events 29 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.4%
6/39 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
32.5%
13/40 • Number of events 16 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
20.0%
8/40 • Number of events 9 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
5/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.8%
5/39 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
17.5%
7/40 • Number of events 11 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
4/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
12.5%
5/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
12.5%
5/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
20.0%
8/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.8%
5/39 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.8%
5/39 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
6/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.4%
6/39 • Number of events 9 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 9 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
7.5%
3/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
4/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.8%
5/39 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Troponin T increased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
12.5%
5/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 16 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.5%
7/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.3%
4/39 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 8 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.5%
3/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
1/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.4%
6/39 • Number of events 10 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
4/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
2/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.4%
6/39 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
4/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.1%
2/39 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.5%
5/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/40 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.5%
3/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
4/40 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.7%
3/39 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
22.5%
9/40 • Number of events 11 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
15.0%
6/40 • Number of events 6 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
4/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
12.8%
5/39 • Number of events 7 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
10.0%
4/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
2.6%
1/39 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 4 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
7.5%
3/40 • Number of events 5 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
0.00%
0/39 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 2 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
5.0%
2/40 • Number of events 3 • AEs: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months. Mortality: Up to 21.2 months.
Mortality is reported for all enrolled participants. AEs and SAEs are reported for the Safety Analysis Set, which includes all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER