Trial Outcomes & Findings for A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT04222972)
NCT ID: NCT04222972
Last Updated: 2026-03-05
Results Overview
PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
Up to approximately 50 months
Results posted on
2026-03-05
Participant Flow
A total of 223 participants with rearranged during transfection (RET) fusion-positive metastatic non-small cell lung cancer (NSCLC) took part in the study at 74 investigative sites across 22 countries from 24 July 2020 to 27 January 2025. The study consists of a treatment period and a crossover period.
Participants in treatment period were randomized in 1:1 ratio to receive standard of care (SOC) platinum containing anticancer treatment regimens (Arm A) or pralsetinib (Arm B). Participants with disease progression (PD) in Arm A had the option to crossover \& receive pralsetinib (Arm C), which was later discontinued as of Protocol Version 5. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
Participant milestones
| Measure |
Arm A: Treatment Period- SOC
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
Participants received pralsetinib, 400 milligrams (mg), orally, once a day (QD) on Day 1 of each cycle until PD, post-trial access program (PTAP), pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Treatment Period
STARTED
|
113
|
110
|
0
|
|
Treatment Period
Safety-evaluable Population
|
104
|
108
|
0
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
113
|
110
|
0
|
|
Crossover Period
STARTED
|
0
|
0
|
38
|
|
Crossover Period
COMPLETED
|
0
|
0
|
0
|
|
Crossover Period
NOT COMPLETED
|
0
|
0
|
38
|
Reasons for withdrawal
| Measure |
Arm A: Treatment Period- SOC
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
Participants received pralsetinib, 400 milligrams (mg), orally, once a day (QD) on Day 1 of each cycle until PD, post-trial access program (PTAP), pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Treatment Period
Adverse Event
|
3
|
1
|
0
|
|
Treatment Period
Death
|
26
|
29
|
0
|
|
Treatment Period
Informed Consent Withdrawn
|
19
|
8
|
0
|
|
Treatment Period
Lost to Follow-up
|
1
|
3
|
0
|
|
Treatment Period
Reason Not Specified
|
9
|
6
|
0
|
|
Treatment Period
Progressive Disease
|
3
|
10
|
0
|
|
Treatment Period
Study Terminated by Sponsor
|
52
|
53
|
0
|
|
Crossover Period
Adverse Event
|
0
|
0
|
2
|
|
Crossover Period
Death
|
0
|
0
|
8
|
|
Crossover Period
Informed Consent Withdrawn
|
0
|
0
|
2
|
|
Crossover Period
Reason Not Specified
|
0
|
0
|
3
|
|
Crossover Period
Progressive Disease
|
0
|
0
|
2
|
|
Crossover Period
Study Terminated by Sponsor
|
0
|
0
|
21
|
Baseline Characteristics
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 12.3 • n=41 Participants
|
61.6 years
STANDARD_DEVIATION 11.1 • n=35 Participants
|
61.9 years
STANDARD_DEVIATION 11.7 • n=76 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
117 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
106 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
37 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=41 Participants
|
82 Participants
n=35 Participants
|
159 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
27 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
7 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
16 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
43 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
White
|
65 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
133 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
14 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
19 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 50 monthsPopulation: ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS)
|
9.0 months
Interval 7.1 to 11.5
|
18.7 months
Interval 11.1 to 25.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 50 monthsPopulation: ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Objective Response Rate (ORR)
|
41.6 percentage of participants
Interval 32.4 to 51.24
|
65.5 percentage of participants
Interval 55.79 to 74.26
|
—
|
SECONDARY outcome
Timeframe: From randomization to death (up to approximately 50 months)Population: ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Overall Survival (OS)
|
39.8 months
Interval 39.8 to
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
NA months
Interval 29.6 to
Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 50 monthsPopulation: Safety-evaluable population included all participants who receive any amount of any study drug.
An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=104 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=108 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
n=38 Participants
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
104 Participants
|
108 Participants
|
38 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
38 Participants
|
67 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 50 monthsPopulation: Safety-evaluable population included all participants who receive any amount of any study drug. As specified in the protocol, assessment of this outcome measure was limited to the treatment period, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=104 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=108 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
n=38 Participants
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 0: Post-baseline Score 0
|
14 Participants
|
18 Participants
|
3 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 0: Post-baseline Score 1
|
28 Participants
|
22 Participants
|
7 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 0: Post-baseline Score 2
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 0: Post-baseline Score 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 0: Post-baseline ECOG Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline Score 0
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline ECOG 1
|
46 Participants
|
44 Participants
|
17 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline ECOG 2
|
10 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline ECOG 3
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline ECOG 4
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 1: Post-baseline ECOG Missing
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline ECOG Score 2: Post-baseline ECOG Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 50 monthsPopulation: ITT population included all randomized participants whether or not the assigned study treatment is received. Overall number analyzed is the number of participants with an objective response of CR or PR. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate median DOR. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=47 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=72 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Duration of Response (DOR)
|
9.7 months
Interval 7.6 to 15.9
|
20.6 months
Interval 17.2 to 31.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 50 monthsPopulation: ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
CBR was defined as the percentage of participants who experienced the best response of stable disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator with use of RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Clinical Benefit Rate (CBR)
|
58.4 percentage of participants
Interval 48.76 to 67.6
|
74.5 percentage of participants
Interval 65.35 to 82.37
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 50 monthsPopulation: ITT population included all randomized participants whether or not the assigned study treatment is received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
DCR was defined as the percentage of participants who experienced the best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off.
Outcome measures
| Measure |
Arm A: Treatment Period- SOC
n=113 Participants
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=110 Participants
Participants received pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Arm A vs Arm B: Disease Control Rate (DCR)
|
79.6 percentage of participants
Interval 71.04 to 86.64
|
88.2 percentage of participants
Interval 80.64 to 93.55
|
—
|
Adverse Events
Arm A: Treatment Period- SOC
Serious events: 38 serious events
Other events: 103 other events
Deaths: 27 deaths
Arm B: Treatment Period- Pralsetinib
Serious events: 67 serious events
Other events: 106 other events
Deaths: 33 deaths
Arm C: Crossover Period- Pralsetinib
Serious events: 22 serious events
Other events: 38 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm A: Treatment Period- SOC
n=104 participants at risk
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=108 participants at risk
Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
n=38 participants at risk
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Myocarditis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Keratitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Asthenia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Catheter site pain
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Chest pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Death
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Fatigue
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
General physical health deterioration
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Malaise
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
COVID-19
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Device related infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Diverticulitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Escherichia infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
14.8%
16/108 • Number of events 16 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Q fever
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Sepsis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Septic shock
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Neutrophil count decreased
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Eating disorder symptom
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Brain oedema
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.96%
1/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Seizure
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Product Issues
Device dislocation
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
4.6%
5/108 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
3/104 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Vascular disorders
Embolism
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Vascular disorders
Thrombophlebitis migrans
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
Other adverse events
| Measure |
Arm A: Treatment Period- SOC
n=104 participants at risk
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
|
Arm B: Treatment Period- Pralsetinib
n=108 participants at risk
Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
|
Arm C: Crossover Period- Pralsetinib
n=38 participants at risk
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
45.2%
47/104 • Number of events 63 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
48.1%
52/108 • Number of events 71 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
26.3%
10/38 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
5/104 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
12.0%
13/108 • Number of events 16 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.3%
19/104 • Number of events 31 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
25.0%
27/108 • Number of events 46 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.4%
7/38 • Number of events 23 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.5%
12/104 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
9/104 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Dry eye
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Eyelid oedema
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Lacrimation increased
|
7.7%
8/104 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Eye disorders
Vision blurred
|
4.8%
5/104 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
8/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.2%
11/108 • Number of events 11 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
3/104 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.7%
9/104 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
9.3%
10/108 • Number of events 16 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
28.8%
30/104 • Number of events 44 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
43.5%
47/108 • Number of events 55 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
31.6%
12/38 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.2%
22/104 • Number of events 31 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
40.7%
44/108 • Number of events 68 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.0%
14/108 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
48/104 • Number of events 85 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.5%
20/108 • Number of events 23 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.2%
5/38 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
8/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.9%
15/108 • Number of events 19 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
11/104 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
9.3%
10/108 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Asthenia
|
36.5%
38/104 • Number of events 53 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
25.0%
27/108 • Number of events 35 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.4%
7/38 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Chest pain
|
7.7%
8/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Face oedema
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
4.6%
5/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Fatigue
|
21.2%
22/104 • Number of events 28 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
16.7%
18/108 • Number of events 21 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Mucosal inflammation
|
11.5%
12/104 • Number of events 14 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Oedema peripheral
|
13.5%
14/104 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
15.7%
17/108 • Number of events 18 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.2%
5/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Pain
|
8.7%
9/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
General disorders
Pyrexia
|
12.5%
13/104 • Number of events 15 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
21.3%
23/108 • Number of events 36 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
5.8%
6/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
COVID-19
|
18.3%
19/104 • Number of events 19 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
20.4%
22/108 • Number of events 22 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Conjunctivitis
|
12.5%
13/104 • Number of events 16 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Herpes zoster
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
6/104 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Oral candidiasis
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Pneumonia
|
4.8%
5/104 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
8/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
15.7%
17/108 • Number of events 27 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.2%
5/38 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
22/104 • Number of events 27 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
36.1%
39/108 • Number of events 68 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.4%
7/38 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
18.3%
19/104 • Number of events 24 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
41.7%
45/108 • Number of events 75 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
21.1%
8/38 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.8%
4/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Blood bicarbonate decreased
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.2%
11/108 • Number of events 24 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Blood creatinine increased
|
8.7%
9/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
23.1%
25/108 • Number of events 30 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.2%
5/38 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.8%
4/104 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
8.3%
9/108 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
7/104 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Neutrophil count decreased
|
7.7%
8/104 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
14.8%
16/108 • Number of events 37 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.2%
5/38 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Platelet count decreased
|
5.8%
6/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
Weight decreased
|
5.8%
6/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Investigations
White blood cell count decreased
|
2.9%
3/104 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
8.3%
9/108 • Number of events 27 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.1%
23/104 • Number of events 25 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.5%
20/108 • Number of events 20 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
5/104 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
1.9%
2/108 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.9%
3/104 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.6%
6/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.8%
5/104 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
7/104 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
9.3%
10/108 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.96%
1/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.2%
11/108 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
16/104 • Number of events 24 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.2%
11/108 • Number of events 14 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
13/104 • Number of events 15 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.0%
14/108 • Number of events 17 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
7/104 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.6%
10/104 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
14.8%
16/108 • Number of events 18 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
8.3%
9/108 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Amnesia
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Dizziness
|
8.7%
9/104 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
9.6%
10/104 • Number of events 11 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
25.0%
27/108 • Number of events 29 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
18.4%
7/38 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Headache
|
9.6%
10/104 • Number of events 15 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
9.3%
10/108 • Number of events 21 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
8.7%
9/104 • Number of events 10 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
4.8%
5/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
13.0%
14/108 • Number of events 19 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Nervous system disorders
Sciatica
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.2%
11/108 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Psychiatric disorders
Insomnia
|
6.7%
7/104 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
3.7%
4/108 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Renal and urinary disorders
Dysuria
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.4%
8/108 • Number of events 8 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
4.6%
5/108 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.93%
1/108 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
13/104 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
26.9%
29/108 • Number of events 39 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
21.1%
8/38 • Number of events 9 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.8%
3/108 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
16/104 • Number of events 21 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
16.7%
18/108 • Number of events 21 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
3/104 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
12.0%
13/108 • Number of events 15 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
2.6%
1/38 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
8.3%
9/108 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.9%
2/104 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
4.6%
5/108 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.96%
1/104 • Number of events 1 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/108 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
5.3%
2/38 • Number of events 2 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
6/104 • Number of events 6 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/104 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
6.5%
7/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
0.00%
0/38 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
10/104 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
4.6%
5/108 • Number of events 7 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
7.9%
3/38 • Number of events 3 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
12/104 • Number of events 13 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
16.7%
18/108 • Number of events 19 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
10.5%
4/38 • Number of events 5 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
|
Vascular disorders
Hypertension
|
3.8%
4/104 • Number of events 4 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
29.6%
32/108 • Number of events 41 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
31.6%
12/38 • Number of events 12 • Up to approximately 50 months
All-cause mortality: ITT population included all randomized participants, regardless of whether the assigned study treatment was received. AEs: Safety-evaluable population included all participants who receive any amount of any study drug. 11 randomized participants did not receive any study treatment and were excluded from safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER