Trial Outcomes & Findings for A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery (NCT NCT04026412)
NCT ID: NCT04026412
Last Updated: 2025-07-24
Results Overview
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
925 participants
Primary outcome timeframe
From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)
Results posted on
2025-07-24
Participant Flow
Participant milestones
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm B: Nivo + CCRT/Nivo
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.
|
Arm C: CCRT/Durva
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Overall Study
STARTED
|
287
|
320
|
318
|
|
Overall Study
COMPLETED
|
103
|
138
|
144
|
|
Overall Study
NOT COMPLETED
|
184
|
182
|
174
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm B: Nivo + CCRT/Nivo
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Total
n=925 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
479 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
104 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
354 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
93 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
317 Participants
n=4 Participants
|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 8.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
244 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
703 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participant in Arm A and C were only considered in the analysis.
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)
|
16.69 months
Interval 12.58 to 21.98
|
15.64 months
Interval 13.67 to 19.75
|
—
|
SECONDARY outcome
Timeframe: From randomization untill death (up to approximately 61 months)Population: All enrolled participants who are randomized to any treatment arm in the study.
Overall Survival (OS) for all randomized participants is the time between randomization and the date of death from any cause based on Kaplan-Meier estimates. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Overall Survival (OS)
|
34.60 months
Interval 26.81 to
UL for 95% CI Not estimable due to insufficient number of events.
|
39.49 months
Interval 33.48 to
UL for 95% CI Not estimable due to insufficient number of events.
|
39.79 months
Interval 30.92 to
UL for 95% CI Not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.
Progression-Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)
|
16.82 months
Interval 12.58 to 22.05
|
17.38 months
Interval 14.09 to 22.14
|
15.67 months
Interval 13.77 to 20.83
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.
Objective Response Rate (ORR) is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Objective Response Rate (ORR) by BICR
|
67.6 percentage of participants
Interval 61.8 to 73.0
|
72.2 percentage of participants
Interval 66.9 to 77.0
|
64.5 percentage of participants
Interval 58.9 to 69.7
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.
Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=194 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=231 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=205 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Duration of Response (DoR) by RECIST 1.1 Per BICR
|
25.76 months
Interval 2.1 to 47.9
|
31.84 months
Interval 1.6 to 44.3
|
25.17 months
Interval 1.0 to 44.3
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.
Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=194 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=231 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=205 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Time to Response (TTR) by RECIST 1.1 Per BICR
|
2.92 months
Interval 0.9 to 22.2
|
2.96 months
Interval 1.3 to 41.9
|
2.92 months
Interval 1.2 to 24.9
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment
|
16.82 months
Interval 13.83 to 20.4
|
17.71 months
Interval 13.83 to 24.71
|
16.53 months
Interval 13.77 to 19.38
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by investigator assessment per response evaluation criteria in solid tumors (RECIST) v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment
|
61.3 percentage of participants
Interval 55.4 to 67.0
|
63.1 percentage of participants
Interval 57.6 to 68.4
|
57.9 percentage of participants
Interval 52.2 to 63.4
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.
Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per investigator assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=176 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=202 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=184 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment
|
22.83 months
Interval 0.0 to 47.4
|
33.18 months
Interval 0.0 to 47.6
|
27.93 months
Interval 0.0 to 46.5
|
SECONDARY outcome
Timeframe: From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study. Participants with CR or PR were included in the analysis.
Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=176 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=202 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=184 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment
|
2.96 months
Interval 1.9 to 25.2
|
2.92 months
Interval 1.9 to 16.5
|
2.89 months
Interval 1.4 to 22.1
|
SECONDARY outcome
Timeframe: From randomization until metastases or death, whichever occurs first (up to approximately 61 months)Population: Intent-to-Treat population includes all enrolled participants who are randomized to any treatment arm in the study.
Time to Death or Distant Metastases (TDDM) is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis based on Kaplan-Meier estimates. Distant metastasis is defined as any new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed by the Investigator.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=287 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=320 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Time to Death or Distant Metastases (TDDM)
|
30.65 months
Interval 22.57 to
UL of 95% CI not estimable due to insufficient number of events
|
36.14 months
Interval 25.86 to
UL of 95% CI not estimable due to insufficient number of events
|
30.36 months
Interval 21.62 to 40.15
|
SECONDARY outcome
Timeframe: From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months)Population: All treated participants
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=282 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=318 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=317 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
ADVERSE EVENTS
|
279 Participants
|
315 Participants
|
312 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
SERIOUS ADVERSE EVENTS
|
155 Participants
|
156 Participants
|
136 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
GASTROINTESTINAL ADVERSE EVENT
|
67 Participants
|
60 Participants
|
54 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
HEPATIC ADVERSE EVENT
|
55 Participants
|
59 Participants
|
72 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
PULMONARY ADVERSE EVENT
|
87 Participants
|
92 Participants
|
55 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
RENAL ADVERSE EVENT
|
25 Participants
|
16 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
SKIN ADVERSE EVENT
|
111 Participants
|
115 Participants
|
115 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs
HYPERSENSITIVITY/INFUSION REACTION
|
18 Participants
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 48Population: All randomized participants. Only participants with data available at the specified timepoint are included in the analysis.
The NSCLC-SAQ is a questionnaire used in clinical trials to understand how non-small cell lung cancer (NSCLC) affects your daily life and well-being. It has 7 questions that ask about your symptoms over the past 7 days, including cough, pain, shortness of breath, fatigue, and appetite loss. The total scores from the questionnaire range from 0 to 20. A higher score means you have more severe symptoms and are feeling worse, which is a bad outcome. A lower score means you have fewer symptoms and are feeling better, which is a good outcome.
Outcome measures
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=83 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm C: CCRT/Durva
n=109 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
Arm C: CCRT/Durva
n=120 Participants
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48
|
-0.60 Score on a Scale
Standard Deviation 3.260
|
-0.91 Score on a Scale
Standard Deviation 3.507
|
-0.89 Score on a Scale
Standard Deviation 3.731
|
Adverse Events
Arm A:Nivo + CCRT/Nivo + Ipi
Serious events: 180 serious events
Other events: 273 other events
Deaths: 132 deaths
Arm B: Nivo + CCRT/Nivo
Serious events: 181 serious events
Other events: 310 other events
Deaths: 132 deaths
Arm C: CCRT/Durva
Serious events: 145 serious events
Other events: 307 other events
Deaths: 132 deaths
Serious adverse events
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=282 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm B: Nivo + CCRT/Nivo
n=318 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.
|
Arm C: CCRT/Durva
n=317 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
6/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.94%
3/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
2.8%
9/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
6/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.94%
3/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Cardiac failure
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Myocarditis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Pericarditis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Hypophysitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Eye disorders
Eye pain
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Eye disorders
Pterygium
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Colitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
7/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.94%
3/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Haematemesis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
2.5%
8/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Asthenia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Chest pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Chills
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Death
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Fatigue
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
General physical health deterioration
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Hyperthermia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Malaise
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Medical device site fistula
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Pyrexia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Sudden death
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Hepatobiliary disorders
Liver disorder
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Immune system disorders
Anaphylactic reaction
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Immune system disorders
Contrast media allergy
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Immune system disorders
Cytokine release syndrome
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Immune system disorders
Drug hypersensitivity
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Bacterial infection
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Bronchitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
COVID-19
|
3.2%
9/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.5%
11/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.9%
6/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Cellulitis
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Empyema
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Haematological infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Helicobacter gastritis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Infection
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Infectious pleural effusion
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Lung abscess
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Neutropenic sepsis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Otitis media
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia
|
11.7%
33/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.3%
39/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.1%
29/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia bacterial
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia fungal
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
3/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.94%
3/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Sepsis
|
1.8%
5/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Septic shock
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Tuberculosis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Viral infection
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Wound infection
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
1.8%
5/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
6.4%
18/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.7%
15/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
General physical condition abnormal
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Imaging procedure abnormal
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Lymphocyte count decreased
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Platelet count decreased
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.9%
6/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
White blood cell count decreased
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
6.0%
17/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.8%
12/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.4%
14/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.94%
3/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Hemiparesis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Neuralgia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Seizure
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Product Issues
Device dislocation
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Renal and urinary disorders
Renal failure
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Autoimmune lung disease
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
9/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
2.8%
9/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.3%
4/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
4/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.2%
10/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
4.6%
13/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.1%
10/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
4/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
4/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.3%
32/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.1%
32/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.5%
11/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
6/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
6/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.95%
3/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.63%
2/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Arterial thrombosis
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Embolism
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.32%
1/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.35%
1/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Thrombosis
|
0.71%
2/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.31%
1/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
0.00%
0/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
Other adverse events
| Measure |
Arm A:Nivo + CCRT/Nivo + Ipi
n=282 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 360 mg Q3W plus Ipilimumab 1 mg/kg Q6W for up to 1 year.
|
Arm B: Nivo + CCRT/Nivo
n=318 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received intravenous infusion of 360 mg Nivolumab once in 3 weeks (Q3W) Plus concurrent chemoradiotherapy (CCRT) Q3W up to 3 cycles (each cycle of 21 days) followed by recovery of 42 days followed by maintenance treatment of intravenous infusion Nivolumab 480 mg once in 4 weeks Q4W for up to 1 year.
|
Arm C: CCRT/Durva
n=317 participants at risk
Participants with Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) received CCRT Q3W for up to 3 cycles (each cycle is of 21 days) followed by recovery of 42 days followed by intravenous infusion of Durvalumab 10 mg/kg Q2W for up to 1 year.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.0%
124/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
41.5%
132/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
42.3%
134/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.5%
41/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.3%
39/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
14.5%
46/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.8%
22/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.9%
25/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.0%
38/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.2%
57/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
19.5%
62/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
13.9%
44/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.9%
42/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
8.5%
27/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.1%
29/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Hyperthyroidism
|
7.8%
22/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.0%
16/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.0%
16/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Endocrine disorders
Hypothyroidism
|
15.6%
44/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
16.0%
51/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.1%
32/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
20/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.1%
10/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.4%
17/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
8/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.3%
17/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Constipation
|
29.1%
82/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
24.5%
78/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
28.1%
89/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.7%
64/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
19.5%
62/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
16.4%
52/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
24/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.6%
21/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Dysphagia
|
18.8%
53/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
13.2%
42/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.7%
34/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
11/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
1.6%
5/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.0%
19/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
98/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
32.7%
104/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
34.1%
108/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Odynophagia
|
5.3%
15/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
26.2%
74/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
25.5%
81/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
21.8%
69/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
11.7%
33/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.9%
38/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.8%
31/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Asthenia
|
21.3%
60/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
15.7%
50/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.0%
54/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Chest pain
|
4.3%
12/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.5%
11/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.6%
24/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Fatigue
|
21.3%
60/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
19.2%
61/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
24.3%
77/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Non-cardiac chest pain
|
6.7%
19/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.0%
19/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Oedema peripheral
|
7.1%
20/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.8%
12/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Pain
|
3.9%
11/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.7%
18/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
General disorders
Pyrexia
|
20.9%
59/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
14.5%
46/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.9%
41/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
COVID-19
|
10.3%
29/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.9%
41/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
12.3%
39/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Pneumonia
|
14.5%
41/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
13.5%
43/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.7%
34/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
11/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
2.8%
9/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.4%
17/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
17.0%
48/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
14.8%
47/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.7%
56/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
14.5%
41/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
16.4%
52/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
15.1%
48/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
12.4%
35/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
14.5%
46/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.1%
32/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Alanine aminotransferase increased
|
12.8%
36/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.0%
35/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
13.6%
43/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
9.2%
26/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.1%
29/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.7%
37/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
14/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.9%
25/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Blood creatinine increased
|
8.2%
23/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
8.2%
26/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.2%
9/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.3%
17/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.4%
14/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Lymphocyte count decreased
|
9.2%
26/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
13.2%
42/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.3%
23/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Neutrophil count decreased
|
19.1%
54/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
21.7%
69/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
18.0%
57/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Platelet count decreased
|
16.7%
47/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.3%
55/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
15.1%
48/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
Weight decreased
|
8.9%
25/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.5%
24/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.4%
17/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Investigations
White blood cell count decreased
|
23.0%
65/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
23.0%
73/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
19.9%
63/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
79/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
20.1%
64/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
24.3%
77/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
17/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.6%
21/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.6%
21/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.5%
24/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
8.2%
26/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.3%
23/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.9%
25/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.6%
21/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.3%
23/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.3%
29/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.9%
38/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
37/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.9%
38/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
16.1%
51/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
22/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
8.2%
26/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
8.5%
27/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.6%
13/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.1%
29/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
17/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.4%
14/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
7.3%
23/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Dizziness
|
5.0%
14/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.7%
18/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.8%
12/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Headache
|
11.3%
32/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
9.4%
30/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.1%
32/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
4.3%
12/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.0%
16/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Psychiatric disorders
Insomnia
|
12.4%
35/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
11.6%
37/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
10.1%
32/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.1%
82/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
26.1%
83/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
27.4%
87/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
47/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
19.8%
63/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.0%
54/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.9%
11/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.3%
17/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.7%
18/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.3%
12/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
5.3%
17/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
3.8%
12/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
22.0%
62/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
23.9%
76/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
15.1%
48/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.0%
17/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.7%
15/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.3%
20/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.1%
54/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
21.7%
69/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.0%
54/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.0%
17/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
4.1%
13/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
6.0%
19/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.0%
65/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.0%
54/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
16.1%
51/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.1%
51/282 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
17.3%
55/318 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
15.5%
49/317 • All-cause mortality was collected from randomization until death due to any cause (up to approximately 61 months). Serious and Non-serious AEs were collected from first dose (Day 1) till 30 days after the last dose (up to approximately 19 months).
All-cause mortality was collected for intent-to-treat population. Serious and Non-serious AEs were collected for all the treated participants.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER