Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394) (NCT NCT03062358)
NCT ID: NCT03062358
Last Updated: 2025-09-30
Results Overview
OS is the time from randomization to death due to any cause, based on the Kaplan-Meier method for censored data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
453 participants
Primary outcome timeframe
Up to approximately 4 years
Results posted on
2025-09-30
Participant Flow
Male and female participants at least 18 years of age with advanced hepatocellular carcinoma (HCC) after progression on or intolerance to sorafenib or oxaliplatin-based chemotherapy with no curative option were enrolled in this study.
Participant milestones
| Measure |
Pembrolizumab + BSC
Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus best supportive care (BSC).
|
Placebo + BSC
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
153
|
|
Overall Study
Treated
|
299
|
153
|
|
Overall Study
Second Course
|
12
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
300
|
153
|
Reasons for withdrawal
| Measure |
Pembrolizumab + BSC
Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus best supportive care (BSC).
|
Placebo + BSC
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Overall Study
Death
|
269
|
145
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Sponsor Decision
|
29
|
7
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + BSC
n=300 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
52.0 Years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
300 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
300 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
453 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Macrovascular Invasion
Yes
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Macrovascular Invasion
No
|
267 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
403 Participants
n=5 Participants
|
|
Alpha-Fetoprotein (α-Fetoprotein)
< 200 ng/mL
|
131 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Alpha-Fetoprotein (α-Fetoprotein)
≥ 200 ng/mL
|
169 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Region
China
|
255 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Region
Ex-China
|
45 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants based on the treatment group to which they were randomized.
OS is the time from randomization to death due to any cause, based on the Kaplan-Meier method for censored data.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=300 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Overall Survival (OS)
|
14.6 Months
Interval 12.6 to 18.0
|
13.0 Months
Interval 10.5 to 15.1
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants based on the treatment group to which they were randomized.
PFS is the time from randomization to first documented disease progression or death due to any cause per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) based on the Kaplan-Meier method for censored data.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=300 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
2.6 Months
Interval 1.5 to 2.8
|
2.3 Months
Interval 1.4 to 2.8
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants based on the treatment group to which they were randomized.
ORR is the percentage of participants who achieve complete response (CR) or partial response (PR) with confirmation per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=300 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
12.7 Percentage of participants
Interval 9.1 to 17.0
|
1.3 Percentage of participants
Interval 0.2 to 4.6
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants with CR or PR.
DOR is the time from first documented evidence of CR or PR per RECIST 1.1 by BICR until disease progression per RECIST 1.1 by BICR or death, based on Kaplan-Meier method for censored data. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=41 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=2 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Duration Of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
23.9 Months
Interval 2.6 to 44.4
|
5.6 Months
Interval 3.0 to 5.6
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants based on the treatment group to which they were randomized, who achieved CR, PR, or SD for ≥5 weeks prior to evidence of disease progression.
DCR is the percentage of participants who achieve CR, PR, or stable disease (SD) for ≥5 weeks prior to evidence of disease progression per RECIST 1.1 by BICR. CR is the disappearance of all target lesions; PR is at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=158 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=73 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
52.7 Percentage of participants
Interval 46.8 to 58.4
|
47.7 Percentage of participants
Interval 39.6 to 55.9
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All randomized participants based on the treatment group to which they were randomized.
TTP is the time from randomization to first documented disease progression per RECIST 1.1 by BICR, based on Kaplan-Meier method for censored data.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=300 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Time To Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
2.7 Months
Interval 1.5 to 2.8
|
1.7 Months
Interval 1.4 to 2.8
|
SECONDARY outcome
Timeframe: Up to approximately 30 months.Population: Randomized participants who received at least 1 dose of study intervention.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=299 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
|
283 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 27 months.Population: Randomized participants who received at least 1 dose of study intervention.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.
Outcome measures
| Measure |
Pembrolizumab + BSC
n=299 Participants
Participants received 200 mg pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo + BSC
n=153 Participants
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
38 Participants
|
13 Participants
|
Adverse Events
Pembrolizumab First Course
Serious events: 76 serious events
Other events: 272 other events
Deaths: 263 deaths
Placebo First Course
Serious events: 31 serious events
Other events: 135 other events
Deaths: 146 deaths
Pembrolizumab Second Course
Serious events: 1 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pembrolizumab First Course
n=299 participants at risk
Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo First Course
n=153 participants at risk
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Pembrolizumab Second Course
n=12 participants at risk
Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Coronary artery disease
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Prinzmetal angina
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hypophysitis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Ascites
|
2.0%
6/299 • Number of events 6 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
3/299 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastritis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
6/299 • Number of events 6 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Chest discomfort
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Death
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
General physical health deterioration
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Pain
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Pyrexia
|
1.0%
3/299 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Swelling
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
1.3%
4/299 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Dilatation intrahepatic duct acquired
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Dengue fever
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Epiglottitis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Febrile infection
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Hepatitis E
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Infection
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Infectious pleural effusion
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Influenza
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Liver abscess
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pneumonia
|
2.0%
6/299 • Number of events 6 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.0%
3/153 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Pneumonia fungal
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Post procedural infection
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Sepsis
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Soft tissue infection
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
5/299 • Number of events 5 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
2.7%
8/299 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood bilirubin increased
|
3.7%
11/299 • Number of events 11 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Hepatitis B DNA increased
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Platelet count decreased
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.67%
2/299 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.0%
3/299 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Nervous system disorders
Spinal cord compression
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Completed suicide
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.33%
1/299 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.65%
1/153 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.33%
1/299 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
Other adverse events
| Measure |
Pembrolizumab First Course
n=299 participants at risk
Participants received 200 mg pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Placebo First Course
n=153 participants at risk
Participants received placebo by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus BSC.
|
Pembrolizumab Second Course
n=12 participants at risk
Eligible participants randomized to the pembrolizumab first course who stopped pembrolizumab with stable disease (SD) or better, initiated a second course of pembrolizumab at the investigator's discretion at 200 mg of each 3 week cycle for up to 17 cycles up to approximately an additional year
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
45/299 • Number of events 55 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
10.5%
16/153 • Number of events 17 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hyperthyroidism
|
5.4%
16/299 • Number of events 16 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.0%
3/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Endocrine disorders
Hypothyroidism
|
9.7%
29/299 • Number of events 35 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
7.2%
11/153 • Number of events 13 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
17/299 • Number of events 18 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.6%
4/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
20/299 • Number of events 26 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
7.8%
12/153 • Number of events 12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
17/299 • Number of events 20 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.6%
4/153 • Number of events 5 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
15/299 • Number of events 16 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.3%
5/153 • Number of events 5 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Constipation
|
9.0%
27/299 • Number of events 29 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 14 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.7%
47/299 • Number of events 76 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.2%
14/153 • Number of events 20 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
6/299 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.6%
4/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
22/299 • Number of events 24 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.2%
8/153 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
19/299 • Number of events 25 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 11 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Asthenia
|
6.0%
18/299 • Number of events 22 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
7.2%
11/153 • Number of events 13 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Fatigue
|
6.4%
19/299 • Number of events 20 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.9%
9/153 • Number of events 10 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Malaise
|
4.0%
12/299 • Number of events 14 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 10 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
General disorders
Pyrexia
|
17.7%
53/299 • Number of events 70 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
13.7%
21/153 • Number of events 34 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.7%
14/299 • Number of events 16 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.2%
8/153 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
COVID-19
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
32/299 • Number of events 37 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Alanine aminotransferase increased
|
30.1%
90/299 • Number of events 138 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
23.5%
36/153 • Number of events 47 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
41.7%
5/12 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Aspartate aminotransferase increased
|
35.8%
107/299 • Number of events 162 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
29.4%
45/153 • Number of events 59 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
41.7%
5/12 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Bilirubin conjugated increased
|
6.7%
20/299 • Number of events 26 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.6%
7/153 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.4%
43/299 • Number of events 60 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.8%
15/153 • Number of events 19 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.7%
2/12 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood bilirubin increased
|
27.8%
83/299 • Number of events 142 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
26.1%
40/153 • Number of events 48 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood creatinine increased
|
3.3%
10/299 • Number of events 13 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.6%
4/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood glucose increased
|
3.0%
9/299 • Number of events 13 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.0%
3/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.0%
15/299 • Number of events 18 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.3%
5/153 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Gamma-glutamyltransferase increased
|
18.1%
54/299 • Number of events 62 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
15.0%
23/153 • Number of events 25 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
25.0%
3/12 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Hepatitis B DNA increased
|
5.0%
15/299 • Number of events 25 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.3%
5/153 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
30/299 • Number of events 41 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 11 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Neutrophil count decreased
|
13.7%
41/299 • Number of events 98 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
11.1%
17/153 • Number of events 25 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Platelet count decreased
|
21.7%
65/299 • Number of events 134 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.3%
25/153 • Number of events 34 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
Weight decreased
|
8.0%
24/299 • Number of events 26 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.9%
6/153 • Number of events 6 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Investigations
White blood cell count decreased
|
17.1%
51/299 • Number of events 128 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
13.7%
21/153 • Number of events 33 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.7%
44/299 • Number of events 50 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
9.2%
14/153 • Number of events 18 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
17/299 • Number of events 28 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.0%
12/299 • Number of events 19 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
1.3%
2/153 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.0%
36/299 • Number of events 46 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.5%
13/153 • Number of events 14 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.7%
2/12 • Number of events 3 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.7%
17/299 • Number of events 24 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.2%
8/153 • Number of events 12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.4%
19/299 • Number of events 23 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.6%
7/153 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.7%
17/299 • Number of events 23 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.9%
9/153 • Number of events 12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
26/299 • Number of events 28 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.9%
9/153 • Number of events 11 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.33%
1/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
17/299 • Number of events 20 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
7.8%
12/153 • Number of events 16 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Psychiatric disorders
Insomnia
|
6.7%
20/299 • Number of events 20 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
2.6%
4/153 • Number of events 4 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/299 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Renal and urinary disorders
Proteinuria
|
10.4%
31/299 • Number of events 33 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
6.5%
10/153 • Number of events 10 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
16.7%
2/12 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.0%
33/299 • Number of events 44 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.5%
13/153 • Number of events 16 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.67%
2/299 • Number of events 2 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/153 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
8.3%
1/12 • Number of events 1 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.7%
35/299 • Number of events 49 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
3.9%
6/153 • Number of events 6 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.7%
44/299 • Number of events 54 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
5.2%
8/153 • Number of events 8 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
|
Vascular disorders
Hypertension
|
6.0%
18/299 • Number of events 22 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
4.6%
7/153 • Number of events 7 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
0.00%
0/12 • All-cause mortality: from randomization up to approximately 7 years. Adverse events: from first treatment up to approximately 7 years.
All-cause mortality population: All randomized participants. Adverse events population: Randomized participants who received at least 1 dose of study intervention. The following AE preferred terms not related to the drug were excluded: Neoplasm progression, Malignant neoplasm progression and Disease progression.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER