Trial Outcomes & Findings for M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (NCT NCT03840902)
NCT ID: NCT03840902
Last Updated: 2024-01-16
Results Overview
PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months
Results posted on
2024-01-16
Participant Flow
First participant signed informed consent: 16-Apr-2019, Clinical data cut-off: 21-Jul-2021.
Participant milestones
| Measure |
cCRT Plus M7824 Followed by M7824
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
|
Overall Study
Treated
|
74
|
77
|
|
Overall Study
COMPLETED
|
74
|
77
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
cCRT Plus M7824 Followed by M7824
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
1
|
1
|
Baseline Characteristics
M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
cCRT Plus M7824 Followed by M7824
n=75 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=78 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 9.35 • n=99 Participants
|
64.9 Years
STANDARD_DEVIATION 8.94 • n=107 Participants
|
64.8 Years
STANDARD_DEVIATION 9.12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 monthsPopulation: Full Analysis Set (FAS) included all participants who were randomized to study treatment.
PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.
Outcome measures
| Measure |
cCRT Plus M7824 Followed by M7824
n=75 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=78 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
|
3.7 months
Interval 1.9 to 5.6
|
3.7 months
Interval 1.8 to 3.9
|
SECONDARY outcome
Timeframe: Time from randomization up to data cut off (assessed up to 27 months)Population: Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention.
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention.
Outcome measures
| Measure |
cCRT Plus M7824 Followed by M7824
n=74 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=77 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with TEAEs
|
70 Participants
|
74 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with immunotherapy related TEAE
|
48 Participants
|
48 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with cisplatin/etoposide chemotherapy regimen related TEAE
|
7 Participants
|
11 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with carboplatin/paclitaxel chemotherapy regimen related TEAE
|
46 Participants
|
47 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with cisplatin/pemetrexed chemotherapy regimen related TEAE
|
15 Participants
|
11 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Participants with radiotherapy related TEAE
|
59 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: Time from randomization to the date of death due to any cause, assessed up to 27 monthsPopulation: FAS included all participants who were randomized to study treatment.
Overall Survival was defined as the time from randomization to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
Outcome measures
| Measure |
cCRT Plus M7824 Followed by M7824
n=75 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=78 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Overall Survival (OS)
|
4.6 months
Interval 0.1 to 22.3
|
4.3 months
Interval 0.3 to 22.7
|
SECONDARY outcome
Timeframe: Time from randomization up to data cut off (assessed up to 27 months)Population: FAS included all participants who were randomized to study treatment.
ORR was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to RECIST v1.1as adjudicated by the Investigator. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
cCRT Plus M7824 Followed by M7824
n=75 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=78 Participants
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
|
29.3 percentage of participants
Interval 19.4 to 41.0
|
32.1 percentage of participants
Interval 21.9 to 43.6
|
SECONDARY outcome
Timeframe: Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 monthsPopulation: Due to early termination of the study, the data for this outcome measure was not collected.
DOR was defined as the time from first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343Population: Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed.
Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed M7824 concentration-time data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343Population: Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed.
Ctrough was the serum concentration observed immediately before next dosing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization up to data cut off (assessed up to 27 months)Population: Based on recommendations by an external Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study. Subsequently, the data for this outcome measure was not collected and analyzed.
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported.
Outcome measures
Outcome data not reported
Adverse Events
cCRT Plus M7824 Followed by M7824
Serious events: 43 serious events
Other events: 68 other events
Deaths: 13 deaths
cCRT Plus Placebo Followed by Durvalumab
Serious events: 31 serious events
Other events: 72 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
cCRT Plus M7824 Followed by M7824
n=74 participants at risk
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=77 participants at risk
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Atrioventricular block complete
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Asthenia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Death
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Disease progression
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Mucosal inflammation
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Pyrexia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
COVID-19
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Device related infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pneumonia
|
4.1%
3/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pulmonary sepsis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Sepsis
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Septic shock
|
2.7%
2/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
4.1%
3/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Glomerular filtration rate decreased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Brain stem haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Cerebral infarction
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.8%
5/74 • Number of events 8 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Hypotension
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
Other adverse events
| Measure |
cCRT Plus M7824 Followed by M7824
n=74 participants at risk
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 milligrams per square meter (mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel (carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed (50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of 1200 mg of M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
cCRT Plus Placebo Followed by Durvalumab
n=77 participants at risk
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
12.2%
9/74 • Number of events 10 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
11.7%
9/77 • Number of events 11 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.3%
15/74 • Number of events 15 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
18.2%
14/77 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.1%
3/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
13/74 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.5%
7/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.1%
6/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.7%
2/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
13.0%
10/77 • Number of events 12 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.4%
4/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.1%
6/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.8%
5/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.6%
13/74 • Number of events 18 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
10.4%
8/77 • Number of events 8 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.7%
19/74 • Number of events 25 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Hypertension
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Hypotension
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Intermittent claudication
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Orthostatic hypotension
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
5.4%
4/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Dizziness
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Dysgeusia
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Headache
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Somnolence
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Syncope
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Nervous system disorders
Tremor
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Product Issues
Device malfunction
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Psychiatric disorders
Anxiety disorder
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Psychiatric disorders
Delirium
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Psychiatric disorders
Depression
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Anaemia
|
51.4%
38/74 • Number of events 49 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
41.6%
32/77 • Number of events 53 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.2%
9/74 • Number of events 13 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
13.0%
10/77 • Number of events 12 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.0%
20/74 • Number of events 27 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
19.5%
15/77 • Number of events 18 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.9%
11/74 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 8 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Angina pectoris
|
2.7%
2/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Palpitations
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Endocrine disorders
Hyperthyroidism
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Endocrine disorders
Hypothyroidism
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Colitis
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
31.1%
23/74 • Number of events 26 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
44.2%
34/77 • Number of events 43 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dental caries
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
12/74 • Number of events 14 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
15.6%
12/77 • Number of events 13 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
5/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Dysphagia
|
12.2%
9/74 • Number of events 10 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gastritis
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Haematemesis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
35.1%
26/74 • Number of events 29 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
37.7%
29/77 • Number of events 35 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Odynophagia
|
6.8%
5/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Oesophagitis
|
20.3%
15/74 • Number of events 15 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
31.2%
24/77 • Number of events 25 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Proctalgia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
9/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
9/74 • Number of events 12 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Asthenia
|
17.6%
13/74 • Number of events 19 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Catheter site pruritus
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Chest discomfort
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Chest pain
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Chills
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Fatigue
|
6.8%
5/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
18.2%
14/77 • Number of events 15 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Feeling hot
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Gait disturbance
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Generalised oedema
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Hyperthermia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Infusion site extravasation
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Infusion site reaction
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Malaise
|
6.8%
5/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
7.8%
6/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Mucosal haemorrhage
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Mucosal inflammation
|
6.8%
5/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Pain
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
General disorders
Pyrexia
|
24.3%
18/74 • Number of events 22 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
13.0%
10/77 • Number of events 11 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Hepatobiliary disorders
Bile duct stone
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Immune system disorders
Hypersensitivity
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
COVID-19
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Device related infection
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Empyema
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Folliculitis
|
2.7%
2/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Fungal skin infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Gingivitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Herpes zoster
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Influenza
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Molluscum contagiosum
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Oesophageal candidiasis
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Oesophageal infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Oral candidiasis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Peri-implantitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Periodontitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pharyngotonsillitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pneumonia
|
10.8%
8/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Pseudomembranous colitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Respiratory tract infection
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Tinea infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Tracheitis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
6/74 • Number of events 10 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation fibrosis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation fibrosis - lung
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
17.6%
13/74 • Number of events 13 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
16.9%
13/77 • Number of events 15 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
9.5%
7/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
11.7%
9/77 • Number of events 12 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
6.8%
5/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
13.0%
10/77 • Number of events 10 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
6/74 • Number of events 10 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
11.7%
9/77 • Number of events 11 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Amylase increased
|
6.8%
5/74 • Number of events 11 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Anti-transglutaminase antibody increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
8.1%
6/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 11 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood bilirubin increased
|
4.1%
3/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood cholesterol increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood creatine increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.4%
4/74 • Number of events 8 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood creatinine increased
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood glucose increased
|
2.7%
2/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Blood urea increased
|
2.7%
2/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Brain natriuretic peptide increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
C-reactive protein increased
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Fibrin D dimer increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.8%
5/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
9.1%
7/77 • Number of events 13 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Gastric pH decreased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Glomerular filtration rate decreased
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Lipase increased
|
10.8%
8/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Lung diffusion test decreased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Lymphocyte count decreased
|
14.9%
11/74 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
16.9%
13/77 • Number of events 23 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
23.0%
17/74 • Number of events 28 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
26.0%
20/77 • Number of events 36 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Platelet count decreased
|
14.9%
11/74 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
16.9%
13/77 • Number of events 21 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Procalcitonin increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Protein total decreased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Prothrombin time prolonged
|
1.4%
1/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Pulmonary function test decreased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Total bile acids increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Transaminases increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Weight decreased
|
10.8%
8/74 • Number of events 9 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
10.4%
8/77 • Number of events 8 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
Weight increased
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
White blood cell count decreased
|
32.4%
24/74 • Number of events 37 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
37.7%
29/77 • Number of events 59 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Investigations
White blood cell count increased
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Cachexia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.0%
17/74 • Number of events 20 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
20.8%
16/77 • Number of events 17 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
2/74 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.1%
6/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.1%
3/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.5%
10/74 • Number of events 16 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
6.5%
5/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
4/74 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.4%
4/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.1%
6/74 • Number of events 13 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
11.7%
9/77 • Number of events 15 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.8%
5/74 • Number of events 5 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
2.6%
2/77 • Number of events 2 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
7/74 • Number of events 7 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
3.9%
3/77 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
6/74 • Number of events 6 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
5.2%
4/77 • Number of events 4 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/74 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.4%
1/74 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
0.00%
0/77 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.1%
3/74 • Number of events 3 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
1.3%
1/77 • Number of events 1 • Time from randomization up to data cut off (assessed up to 27 months)
Safety (SAF) Analysis Set included all participants who were administered any dose of any study intervention. All-Cause Mortality was assessed on Full Analysis Set, Serious Adverse Events or Other (Not Including Serious) Adverse Events was done on Safety (SAF) Analysis Set.
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place