Trial Outcomes & Findings for Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC) (NCT NCT03358875)
NCT ID: NCT03358875
Last Updated: 2025-02-10
Results Overview
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
805 participants
Primary outcome timeframe
From randomization to the data cutoff date of 10 August 2020; up to 32.4 months
Results posted on
2025-02-10
Participant Flow
This study was conducted at 109 study centers in 10 countries (China, Brazil, Bulgaria, Lithuania, Mexico, New Zealand, Poland, Russia, Slovakia, and Turkey).
Eligible participants were randomized in a 2:1 ratio to receive either tislelizumab or docetaxel treatment. Randomization was stratified by histology (squamous versus non--squamous), line of therapy (second line versus third line), and programmed cell death protein ligand-1 (PD-L1) expression (≥ 25% tumor cells (TCs) versus \< 25% TCs).
Participant milestones
| Measure |
Tislelizumab
Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
535
|
270
|
|
Overall Study
Received Treatment
|
534
|
258
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
535
|
270
|
Reasons for withdrawal
| Measure |
Tislelizumab
Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Overall Study
Death
|
409
|
223
|
|
Overall Study
Study Closed by Sponsor
|
66
|
29
|
|
Overall Study
Withdrawal by Subject
|
13
|
16
|
|
Overall Study
Lost to Follow-up
|
13
|
2
|
|
Overall Study
Miscellaneous
|
33
|
0
|
|
Overall Study
Remained on Study
|
1
|
0
|
Baseline Characteristics
Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=535 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=270 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Total
n=805 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 8.79 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.95 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
416 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
622 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
424 Participants
n=5 Participants
|
219 Participants
n=7 Participants
|
643 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histology
Squamous
|
248 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
370 Participants
n=5 Participants
|
|
Histology
Non-Squamous
|
287 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Current Line of Therapy
Second line
|
453 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
682 Participants
n=5 Participants
|
|
Current Line of Therapy
Third line
|
82 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
PD-L1 Expression
≥ 25% of tumor cells
|
227 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
PD-L1 Expression
< 25% of tumor cells
|
307 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
459 Participants
n=5 Participants
|
|
PD-L1 Expression
Missing
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Smoking Status
Never
|
162 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Smoking Status
Current
|
50 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Smoking Status
Former
|
323 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the data cutoff date of 10 August 2020; up to 32.4 monthsPopulation: The Intent-to-Treat (ITT) Analysis Set included all randomized patients
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
Outcome measures
| Measure |
Tislelizumab
n=535 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=270 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS) in All Participants (Co-primary Endpoint)
|
17.2 months
Interval 15.28 to 20.04
|
11.9 months
Interval 10.18 to 13.93
|
PRIMARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining).
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
Outcome measures
| Measure |
Tislelizumab
n=227 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=115 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)
|
19.3 months
Interval 16.49 to 22.6
|
11.5 months
Interval 8.15 to 13.54
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: Intent-to-Treat Analysis Set
Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.
Outcome measures
| Measure |
Tislelizumab
n=535 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=270 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Objective Response Rate (ORR) in All Participants
|
22.6 percentage of participants
Interval 19.14 to 26.4
|
7.0 percentage of participants
Interval 4.29 to 10.77
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: The PD-L1-Positive Analysis Set included all randomized patients whose tumors were PD-L1 positive (defined as ≥ 25% of tumor cells with PD-L1 membrane staining).
Objective response rate is defined as the percentage of participants who had a complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the chest, abdomen, and pelvis. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the size of target lesions and no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.
Outcome measures
| Measure |
Tislelizumab
n=227 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=115 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Objective Response Rate in PD-L1-Positive Participants
|
37.4 percentage of participants
Interval 31.13 to 44.09
|
7.0 percentage of participants
Interval 3.05 to 13.25
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: Participants in the Intent-to-Treat Analysis Set who had an objective response
DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
Outcome measures
| Measure |
Tislelizumab
n=121 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=19 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR) for All Responders
|
13.5 months
Interval 8.54 to 19.58
|
6.0 months
Interval 2.1 to 7.16
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: Participants in the PD-L1-Positive Analysis Set who had an objective response
DoR was defined as the time from the first documented objective response to documented disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or the appearance of any new lesions.
Outcome measures
| Measure |
Tislelizumab
n=85 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=8 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DOR) in PD-L1-Positive Responders
|
11.9 months
Interval 8.31 to 19.58
|
4.2 months
Interval 0.56 to 6.05
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: Intent-to-Treat Analysis Set
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Tislelizumab
n=535 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=270 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Progression-free Survival (PFS) in All Participants
|
4.2 months
Interval 3.88 to 5.52
|
2.6 months
Interval 2.17 to 3.78
|
SECONDARY outcome
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 monthsPopulation: PD-L1 Positive Analysis Set
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Tislelizumab
n=227 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=115 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Progression-free Survival in PD-L1 Positive Participants
|
6.5 months
Interval 6.24 to 8.28
|
2.5 months
Interval 2.1 to 4.11
|
SECONDARY outcome
Timeframe: Baseline and Cycle 6 (each cycle was 3 weeks)Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis.
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and two global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS/QoL score indicates better quality of life.
Outcome measures
| Measure |
Tislelizumab
n=316 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=76 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score
|
2.4 score on a scale
Interval 0.62 to 4.12
|
-3.4 score on a scale
Interval -6.45 to -0.27
|
SECONDARY outcome
Timeframe: Baseline and Cycle 6 (each cycle was 3 weeks)Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at baseline and Cycle 6 are included in the analysis.
The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores indicate an improvement in symptoms.
Outcome measures
| Measure |
Tislelizumab
n=316 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=77 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores
Coughing Scale
|
-7.8 score on a scale
Interval -10.23 to -5.3
|
0.5 score on a scale
Interval -3.87 to 4.87
|
|
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores
Dyspnoea Scale
|
-1.2 score on a scale
Interval -2.93 to 0.56
|
2.0 score on a scale
Interval -1.01 to 5.05
|
|
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores
Chest Pain Scale
|
-0.9 score on a scale
Interval -2.86 to 1.06
|
1.3 score on a scale
Interval -2.15 to 4.84
|
SECONDARY outcome
Timeframe: Baseline and Cycle 6 (each cycle was 3 weeks)Population: The HRQoL Analysis Set included all randomized participants who received ≥ 1 dose of study drug and completed ≥ 1 HRQoL assessment; participants with available data at Baseline and Cycle 6 are included in the analysis.
The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Outcome measures
| Measure |
Tislelizumab
n=237 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=60 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
|
1.0 score on a scale
Standard Deviation 11.89
|
1.7 score on a scale
Standard Deviation 11.36
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months)Population: The Safety Analysis Set included all randomized patients who received ≥ 1 dose of study drug.
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. The investigator assessed the severity of each AE and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 as defined below: * Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. * Grade 3: Severe or medically significant but not immediately life threatening. hospitalization or prolongation of hospitalization indicated; disabling; limiting selfcare activities of daily living. * Grade 4: Life threatening consequences; urgent intervention indicated. * Grade 5: Death related to AE.
Outcome measures
| Measure |
Tislelizumab
n=534 Participants
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=258 Participants
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
518 Participants
|
254 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
≥ Grade 3 TEAE
|
233 Participants
|
193 Participants
|
Adverse Events
Tislelizumab
Serious events: 192 serious events
Other events: 498 other events
Deaths: 409 deaths
Docetaxel
Serious events: 84 serious events
Other events: 246 other events
Deaths: 223 deaths
Serious adverse events
| Measure |
Tislelizumab
n=534 participants at risk
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=258 participants at risk
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.9%
5/258 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.1%
21/258 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.3%
6/258 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.3%
11/258 • Number of events 12 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Myocarditis
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.94%
5/534 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Immune-mediated adrenal insuficiency
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Eye disorders
Retinal tear
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.19%
1/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest pain
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chills
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Death
|
1.1%
6/534 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Bronchitis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
7.3%
39/534 • Number of events 48 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.4%
19/258 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Septic shock
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Cerebral radiation injury
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
8/258 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.6%
4/258 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.94%
5/534 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
1/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.56%
3/534 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Seizure
|
0.19%
1/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.37%
2/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Visual pathway disorder
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Depression
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.75%
4/534 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
8/534 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.9%
5/258 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
10/534 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.6%
4/258 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
1.5%
8/534 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.3%
7/534 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
9/534 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.9%
5/258 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
15/534 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.37%
2/534 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
6/534 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.2%
3/258 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.56%
3/534 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Embolism venous
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.19%
1/534 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Other adverse events
| Measure |
Tislelizumab
n=534 participants at risk
Participants received tislelizumab 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
Docetaxel
n=258 participants at risk
Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.
|
|---|---|---|
|
Investigations
Blood urea increased
|
4.9%
26/534 • Number of events 38 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
29.2%
156/534 • Number of events 269 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
44.2%
114/258 • Number of events 169 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.0%
13/258 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
17/534 • Number of events 38 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
27.1%
70/258 • Number of events 169 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
10/534 • Number of events 24 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
28.3%
73/258 • Number of events 185 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
20/534 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
9/258 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
4.3%
23/534 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/258 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
12.4%
66/534 • Number of events 82 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Eye disorders
Cataract
|
4.1%
22/534 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
8/534 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.7%
12/258 • Number of events 14 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
16/534 • Number of events 20 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
10/258 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
13.9%
74/534 • Number of events 89 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
17.1%
44/258 • Number of events 51 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
41/534 • Number of events 52 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
13.6%
35/258 • Number of events 51 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
12.2%
65/534 • Number of events 73 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
16.7%
43/258 • Number of events 55 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
6/534 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.7%
12/258 • Number of events 14 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
20/534 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.3%
6/258 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
35/534 • Number of events 44 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.4%
19/258 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
14.2%
76/534 • Number of events 78 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
22.1%
57/258 • Number of events 64 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
3.6%
19/534 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
8/258 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest pain
|
3.9%
21/534 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 2 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
6.9%
37/534 • Number of events 40 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
9.3%
24/258 • Number of events 31 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
7.5%
40/534 • Number of events 44 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.6%
17/258 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
4.1%
22/534 • Number of events 29 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
2.8%
15/534 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
10/258 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
11.6%
62/534 • Number of events 72 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.1%
26/258 • Number of events 29 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
7.5%
40/534 • Number of events 43 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
18/258 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
55/534 • Number of events 76 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.9%
23/258 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
21.0%
112/534 • Number of events 183 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.1%
39/258 • Number of events 47 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
19.9%
106/534 • Number of events 172 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
12.4%
32/258 • Number of events 38 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
3.2%
17/534 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.3%
39/534 • Number of events 53 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
10/258 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
6.7%
36/534 • Number of events 49 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.8%
15/258 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
3.9%
21/534 • Number of events 34 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.8%
47/534 • Number of events 97 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.78%
2/258 • Number of events 4 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatinine increased
|
6.9%
37/534 • Number of events 58 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.6%
17/258 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.1%
38/534 • Number of events 48 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
18/258 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.0%
32/534 • Number of events 56 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.2%
3/258 • Number of events 3 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.8%
31/534 • Number of events 47 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.8%
15/258 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.6%
35/534 • Number of events 76 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
18/258 • Number of events 37 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
3.2%
17/534 • Number of events 38 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
34.9%
90/258 • Number of events 168 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count increased
|
3.6%
19/534 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
3.9%
21/534 • Number of events 37 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
9/258 • Number of events 11 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
16.9%
90/534 • Number of events 101 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
12.0%
31/258 • Number of events 32 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
3.9%
21/534 • Number of events 58 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
29.1%
75/258 • Number of events 133 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count increased
|
3.7%
20/534 • Number of events 30 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.3%
11/258 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.5%
88/534 • Number of events 95 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
24.0%
62/258 • Number of events 71 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
56/534 • Number of events 111 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.2%
29/258 • Number of events 37 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.5%
24/534 • Number of events 52 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.2%
76/534 • Number of events 141 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.5%
40/258 • Number of events 64 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
29/534 • Number of events 49 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.1%
21/258 • Number of events 26 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
3.6%
19/534 • Number of events 29 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.3%
11/258 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.6%
51/534 • Number of events 83 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.4%
14/258 • Number of events 16 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.9%
53/534 • Number of events 85 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.9%
28/258 • Number of events 37 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.1%
11/534 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
9/258 • Number of events 16 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
4.1%
22/534 • Number of events 27 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 8 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
68/534 • Number of events 83 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.9%
23/258 • Number of events 30 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
41/534 • Number of events 47 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.8%
20/258 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
6/534 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.2%
16/258 • Number of events 19 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
29/534 • Number of events 36 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.6%
17/258 • Number of events 23 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.9%
21/534 • Number of events 25 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
8/258 • Number of events 9 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
3.6%
19/534 • Number of events 21 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.0%
13/258 • Number of events 15 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
4.3%
23/534 • Number of events 28 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.7%
12/258 • Number of events 12 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.1%
6/534 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.0%
13/258 • Number of events 13 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/534 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
9/258 • Number of events 10 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
6.4%
34/534 • Number of events 58 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.1%
26/258 • Number of events 29 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
17/534 • Number of events 26 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.3%
6/258 • Number of events 6 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
111/534 • Number of events 128 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.5%
40/258 • Number of events 46 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
62/534 • Number of events 64 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
12.0%
31/258 • Number of events 35 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.6%
51/534 • Number of events 62 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.6%
17/258 • Number of events 18 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
36/534 • Number of events 49 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.5%
22/258 • Number of events 22 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.3%
7/534 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
49.2%
127/258 • Number of events 130 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
41/534 • Number of events 44 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.9%
5/258 • Number of events 5 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
38/534 • Number of events 41 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.7%
7/258 • Number of events 7 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
4.7%
25/534 • Number of events 32 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.39%
1/258 • Number of events 1 • All-cause mortality is reported from randomization up to study completion date cut-off date of 18 January 2024, up to 63 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date cut-off date of 18 January 2024, up to 63 months.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER